Method of making inflatable medical devices

ABSTRACT

Inflatable medical devices and methods for making and using the same are disclosed. The inflatable medical devices can be medical balloons. The balloons can be configured to have a through-lumen or no through-lumen and a wide variety of geometries. The device can have a high-strength, non-compliant, fiber-reinforced, multi-layered wall. The inflatable medical device can be used for angioplasty, kyphoplasty, percutaneous aortic valve replacement, or other procedures described herein.

CROSS-REFERENCE TO RELATED APPLICATIONS

This application claims priority to U.S. Provisional Application Nos.61/057,986, filed 2 Jun. 2008; 61/086,739, filed 6 Aug. 2008;61/105,385, filed 14 Oct. 2008; and 61/205,866, filed 22 Jan. 2009 whichare incorporated by reference herein in their entireties.

BACKGROUND OF THE INVENTION

1. Field of the Invention

This invention relates to inflatable structures for use in medicine andother applications, and methods of manufacture and use of the same.

2. Description of the Related Art

Inflatable structures, such as balloons, are widely used in medicalprocedures. A balloon is inserted, typically on the end of a catheter,until the balloon reaches the area of interest. Adding pressure to theballoon causes the balloon to inflate. In one variation of use, theballoon creates a space inside the body when the balloon inflates.

Balloons may be used to move plaque away from the center of a vascularlumen toward the vasculature walls, such as during an angioplasty or aperipheral vasculature procedure. During this procedure, a balloontipped catheter is placed in a vascular obstruction. As the balloon isinflated, the vessel constriction is dilated, resulting in improvedblood flow.

Optionally, the balloon may have a stent placed over it. The balloonexpands the stent in order to create a scaffold structure that keeps thevessel from constricting after the balloon is removed. Stents are usedthroughout the body, including the coronaries, other portions of thevasculature, the GI tract, the biliary ducts and the urinary andgynecologic tracts.

High pressure balloons may be used to expand constrictions in bone, suchas in the sinuses in sinuplasty.

Balloons may be designed to make space in bone. After an osteoporoticcompression or trauma-induced fracture in a vertebral body, a ballooncan be inserted into the vertebral body through a working channel suchas a cannula. The balloon is then inflated, creating a void in the bone.The balloon is withdrawn and bone cement is injected to internallystabilize the fracture. This procedure may be referred to asKyphoplasty.

Sometimes the vasculature has a narrowing that is calcified, which cancreate a particularly difficult obstruction for dilation. As the vesselis increasingly narrowed, it can become what is known as a CTO (ChronicTotal Occlusion). CTOs can be difficult to pass through with a devicesuch as a guidewire or catheter and can be difficult to dilate or open.The balloon used to open a CTO is ideally resistant to puncture andoperates at a very high pressure.

Balloons can have structures attached to their surface. These structurescan include blades or stiffening rods. These structures may slice avessel open. These structures may apply pressure to the inside of avessel in order to expand the vessel.

Balloons can be used to locally deliver captured volumes of aradioactive substance. The procedure may be known as brachytherapy.

Balloons can be used to intentionally obstruct vessels. Stenting of thecarotids serves to treat atherosclerotic carotid vessels. Stenting ofthe carotids may be less invasive than an endarterectomy. Stenting ofthe carotids may release a stream of debris that can travel to thebrain, causing strokes. Expanding a balloon in the carotid artery abovethe area of treatment can prevent this debris movement to the brain,thereby reducing the potential for adverse complications.

Balloons may be used to position and deploy arterial grafts that repairaneurysms.

A balloon may deliver targeted drugs in the body by isolating a spacefor treatment.

A balloon may deliver targeted drugs in the body by having many tinyholes in the balloon wall. The holes in the balloon wall may allow thedrug to slowly flow into the area surrounding the balloon.

Balloons may be used endoscopically to open up constrictions in thebody, such as those in the esophageal tract, the urological tract, thebiliary tract, the fallopian tubes, the carpal tunnel or esophagus, orother portions of the GI tract (the alimentary canal). A balloon may beused to expand constrictions in the urethra, including for BenignProstate Hyperplasia (BPH).

Balloons may be used in the heart valves, including during PercutaneousTransvenous Mitral Valvuloplasty (PTMV) or Percutaneous TransvenousMitral Balloon Commissurotomy (PTMC) or Mitral Annuloplasty. Theballoons can be utilized to expand stenosed or calcifically-narrowedstructures. The balloons can be utilized to expand valves to atissue-opposed diameter.

A balloon may be used to affix a device inside the body. Another devicemay then use the balloon as a structure that the device can reactagainst. The device may use this reaction force to move in the body. Aballoon and a device may be used in the GI tract. A balloon and a devicemay be used during a Double Balloon Enteroscopy procedure, or duringcolonoscopy.

Balloons may be used to create space in the body or to move organs inbody. Balloons can be used to manipulate organs along tissue planes.

The balloon may locate a cutting instrument in some ablative procedures.The balloon may position a diagnostic device.

An inflatable structure can be used to open space in tissue or to pullsclerotic structures apart, or to advance structures introducedherewithin to the body.

A balloon may be used to occupy a volumetric space for long periods oftime, such as a device used to impart satiety at lower food volumes, asin Bariatric procedures.

A balloon can be used to create captured volumes that serve to transferheat or cold. A balloon can provide small crossing profiles that thenexpand locally to create large volumes with high surface areas andintimate tissue contact. This is utilized in the prostate to treat BPH.

Balloons can be used as implants, creating an anatomical conformingstructure advantageous to improved local fit.

Balloons have been suggested which seal against a lumen wall, thencontinue to dynamically seal as they are manipulated backwards orforwards. These balloons may be used in the GI tract. These balloons maybe advanced forward or backward by pressure gradients on either side ofthe balloon.

Balloons may be used as pressure cuffs, such as those found in Lap-Bandbariatric devices. By changing the pressure in the balloon, the innerdiameter can grow or shrink. Changing the diameter alters clinicalresults.

Balloons may be elongated and used for movement through long lumens,including the GI tract.

Inflatable structures can be made into everting tubes, which have beenutilized in gynecologic and urinary procedures, and have been suggestedfor GI procedures.

Two basic types of balloons are utilized: One is a high pressure,low-compliance balloon. The other is a lower pressure, high-complianceballoon.

High-compliance medical balloons are often composed of urethane, latex,silicone, PVC, Pebax, and other elastomers. As the pressure in ahigh-compliant balloon is increased, the balloon dimensions expand. Oncethe pressure is reduced, the high-compliance medical balloon may returnto its original shape, or near its original shape. High-compliancemedical balloons can easily expand several times in volume between zeroinflation pressure and burst.

Traditional high-compliance medical balloons can be inadequate for manyreasons. High-compliance, or highly elastic medical balloons typicallycannot reach high pressures because their walls have a low tensilestrength and their walls thin out as the balloon expands. In someinstances, high-compliance medical balloons provide insufficient forceto complete a procedure. Exceeding the rated pressure of ahigh-compliance medical balloon creates an excessive risk of balloonfailure which can lead to serious complications for the patient.

High-compliance medical balloons also have poor shape control. As ahigh-compliance medical balloon expands, it may assume a shape dictatedmostly by the particulars of the environment inside the patient ratherthan the clinical goals. In some cases, this can be contrary to what themedical practitioner desires. Many medical procedures are predicated onforming a particular balloon shape reliably.

High-compliance medical balloons often suffer from poor punctureresistance.

It is generally desirable that the medical balloon be able to enter andexit the body with as little trauma as possible. Therefore, a smalldeflated balloon profile is an important consideration in balloondesign. This requirement favors materials with high strength to volumeratios. High-compliance medical balloons do not use materials that haveoutstanding strength to volume ratios.

In some cases, it is desirable that the medical balloon have a strongchemical resistance. For instance, a principal component of bone cementis methyl methacrylate, which readily degrades some elastomers, such asurethane. Therefore, many high-compliance medical balloons are notcompatible with the introduction of aspects of the procedure that thehigh-compliance medical balloon is meant to support.

Low-compliance, high pressure medical balloons substantially retaintheir shape under comparatively high pressures. PET (polyethyleneterephthalate) is the most common material for use in high pressurelow-compliance balloons. PET is commonly used for high-performanceangioplasty balloons. PET is stronger than other polymers, can be moldedinto a variety of shapes and can be made very thin (e.g., 5 μm to 50 μm(0.0002 in. to 0.002 in.)), thus giving these balloons a low profile.

Balloons made from PET walls are fragile and prone to tears. Whenpressed against a hard or sharp surface in the body, such as bone, PETballoons have poor puncture resistance. PET is very stiff so balloonsmade from PET may be difficult to pack or fold into a small diameter orwith good trackability (i.e., the ability to slide and bend over aguidewire deployed through a tortuous vessel). In some applications,PET's chemical resistance can lead to unwanted adhesion, degradation ordestruction of a PET balloon during a procedure.

Balloons made from PET, while stronger than most other balloons madefrom homogenous polymers, may still not be strong enough to holdpressures sufficient to complete certain medical procedures.

The PET in a balloon wall may be oriented during manufacture. However,the oriented PET may not have strength in all directions exactlyproportionate to the expected load.

PET, like most low compliance balloons, is usually blow-molded. The blowmolding process makes it difficult or impossible to create certainshapes. Blow molding can result in wall thicknesses in the balloon thatdo not match the material thicknesses to the expected load.

Nylon balloons are an alternative material for low-compliance, highpressure balloons. These balloons are typically weaker than PET balloonsand so can contain less pressure. Nylon readily absorbs water, which canhave an adverse affect on Nylon's material properties in somecircumstances. Nylon has improved puncture resistance over PET and ismore flexible than PET.

Low compliance fiber reinforced medical balloons have recently becomecommercially available for peripheral vascular procedures. High strengthinelastic fibers are used as part of the low compliance fiber reinforcedmedical balloons to strengthen the walls of the balloon while furtherlowering strain rates. High strength inelastic fibers such as Kevlar,Vectran, Dyneema and carbon fiber all have strength to volume ratiosthat greatly exceed that of PET or Nylon. The high strength inelasticfibers are combined with a flexible adhesive and, optionally, one ormore polymer walls to form a balloon.

Low compliance fiber reinforced medical balloons may suffer from severalproblems. These balloons may have a low volume ratio of high strengthinelastic fiber to the total material volume in the balloon walls. It isreasonable to assume that a higher volume ratio of high strengthinelastic fiber to the total material volume in the balloon walls wouldlead to a higher burst pressure for the same wall thickness.

Commercially available low compliance fiber reinforced medical balloonsand the processes that produce them may only allow limited flexibilityin the placement of the high strength inelastic fibers. For example, aprocess may result in fibers aligned along the axis of the balloon andfibers wrapped around the circumference. This limited choice of fiberorientation is not always the optimum way to orient the fibers formaximum strength. This limited choice of fiber orientation is not alwaysthe optimum way to orient fibers to resist puncture or ripping.

Commercially available low compliance fiber reinforced medical balloonsand the processes that produce them may not allow for a large variety ofdifferent balloon shapes to be manufactured.

SUMMARY OF THE INVENTION

Medical inflatable devices for use in a biological body are disclosed.The device can have a balloon. The balloon can have a wall having aninner layer, a first middle layer, and an outer layer. The outer layercan be thinner than about 0.05 mm (0.002 in.), and the inner layer isthinner than about 0.05 mm (0.002 in.). The first middle layer can havea fiber. The outer layer can have a melt or decomposition temperaturegreater than about 200° Celsius.

The outer layer can be made from a thermoset material. The outer layercan be made from PEEK. The outer layer can be made from a polyamide. Theouter layer can be MMA-resistant and/or MMA-releasing. An MMA-resistantlayer can be substantially non-degrading when exposed to MMA, such asuncured MMA. An MMA-releasing layer can be substantially non-binding ornon-adhering to MMA. The MMA-releasing layer can be pulled away andseparated from cured MMA without binding to the MMA.

The first middle layer can be made from a resin. The inner layer can bethinner than about 0.01 mm (0.0004 in.), and the outer layer can bethinner than about 0.01 mm (0.0004 in.). The inner layer can besubstantially air leak-proof.

The balloon can have a wall that can have an inner layer, a first middlelayer, and an outer layer.

The outer layer can be thinner than about 0.05 mm (0.002 in.). The outerlayer can have a thermoset material, such as PEEK. The outer layer canhave a polyamide. The first middle layer can have a fiber and/or aresin.

The wall can have an air leak-proof inner layer and an MMA-resistantouter layer. The outer layer can be thinner than about 0.05 mm (0.002in.), and the inner layer can be thinner than about 0.05 mm (0.002 in.).

The second layer can be radially inside the third layer, and the secondlayer can be radially outside the first layer. The third layer can makeup the radial outermost surface of the wall. The wall can also have afourth layer. The fourth layer can be radially inside the third layer.The fourth layer can be radially outside the first layer. The fourthlayer can have a radiopaque material.

The wall can have a first layer, a second layer, a third layer, and afourth layer. The first layer can be leak-proof and the fourth layer isMMA-resistant. The first layer can be radially inside of the secondlayer, the third layer, and the fourth layer. The fourth layer can beradially outside of the first layer, the second layer, and the thirdlayer. One, two, or three layers can have resin and fiber in contactwith the resin, for example the fiber can be embedded within the resinor in one side of the resin. The layers With the fiber can beMMA-resistant.

The wall can have a layer that can form at least one continuous seamaround the balloon. The balloon can be substantially non-compliant orinelastic. The wall can be less than about 0.1 mm (0.004 in.) thick.

The balloon can have a longitudinal axis having a longitudinal axislength. The balloon can have a fiber having a fiber length. The fiberlength can be about 175% to about 300% of the longitudinal axis length.The wall of the balloon can have a first layer and a second layer. Thefiber can be in the second layer. The first layer can be on the radialinside of the fiber with respect to the balloon, and the first layer canbe leak-proof, and/or MMA-resistant.

The balloon can have an inner diameter of more than about 2 mm, or about13 mm (0.5 in.), or more than about 15 mm. The balloon can have a wallhaving a wall thickness of less than about 0.005 in., and a burstpressure greater than about 150 psi, more narrowly greater than about3,400 kPa (500 psi). For example, the burst pressure of the balloon canbe greater than about 2, 100 kPa (300 psi).

The balloon can have a proximal terminal end and a distal terminal end.The balloon can have a closed distal terminal end, or no through-lumen.Having no through-lumen can include having no longitudinal through-lumenextending through the proximal terminal end and through the distalterminal end. The distal end of the balloon can be atraumatic, forexample blunt.

The balloon can have a reinforcement fiber that can be in a matrix. Thematrix can have a reinforcement fiber and a resin. The resin can be anadhesive. The fibers can be oriented longitudinally and/or around thedistal end of the balloon. The fibers can cover (but not necessarily onthe outer surface) greater than 50% of the area of the balloon-wall. Thematrix can have a thermoplastic material.

The balloon wall can have a first, second and/or more strips. The stripscan have none, one or more reinforcement and/or radiopaque markerfibers. Each strip can have the same or a different number of fibers.The balloon can have a closed distal end. The first strip can overlaythe second strip at the distal end. Additional strips can overlay thefirst and second strips at the distal end or elsewhere along the lengthof the balloon. The strips can intersect at a strip angle. The stripangle can be equal to or greater than about 30 or 45 degrees. Forexample, the strip angle can be about 60 degrees or about 90 degrees.

The first middle layer can have a radiopaque material and besubstantially contiguous throughout the wall. For example, the firstmiddle layer can have a metal foil. The first middle layer can have aradiopaque material in non-powder form. The first middle layer can haveless than about 100 pieces of radiopaque material. The radiopaquematerial can covers (not necessarily on the top surface) at least about30% of the area of the wall of the balloon. The first middle layer canhave a first elongated member that can have a radiopaque material. Forexample, the elongate member can be a strip, such as the strip describedherein.

The first middle layer can have a fiber. The second middle layer canhave a radiopaque material. The first middle layer can be between theinner layer and the second middle layer.

The balloon wall can have a water-proof inner layer, a first middlelayer that can have a fiber, a second middle layer that can have aradiopaque wire, and an outer layer. The fiber can be helicallypositioned or hoop or helically wrapped around the balloon wall.

The radially outer layer of the balloon wall can have a thickness ofless than about 0.0005 in. and the radially outer layer can be resistantto degradation by MMA. The radially outer layer can be made from orcoated with Teflon or PTFE. The MMA-resistant layer can have anMMA-resistant matrix and a fiber. The MMA-resistant matrix can have anadhesive. The balloon can be configured to deliver a radial pressure ofabout 2,800 kPa (400 psi).

The balloon can be shaped having a first side and a second side. Thefirst side can be opposite the second side with respect to the balloonlongitudinal axis. The first side can be substantially flat, and thesecond side can be substantially flat.

The balloon wall can have a wall thickness of equal to or less thanabout 0.3 mm, for example about 0.1 mm, and the balloon has an outerdiameter less than or equal to about 13 mm, and the balloon has a burstpressure of equal to or greater than about 1000 kPa (150 psi).

The balloon wall can have a first layer that can have a reinforcementand/or marker fiber and a second layer that can have a resistive heatingelement, such as tantalum foil. The resistive heating element can be awire helically configured around the balloon. The resistive heatingelement can be controlled by a controller configured to controllablydeliver energy to the resistive heating element. The resistive heatingmaterial can be the elongated strip or in the elongated strip.

The wall can have a semi-rigid panel. The panel can be between an innerand outer layer of the wall. The panel can have a modulus of elasticitygreater than about 1,000,000 and a thickness greater than about 0.0002in. The panel can be a metal foil. The balloon can be pleated beforeuse.

A method for making an inflatable device for use in a biological body isdisclosed. The method can include forming a leak-proof member from solidfilm on a removable mandrel. The forming can occur at a temperaturebelow 100° Celsius. the forming occurs without solvation of the film.The method can further include adhering the film to the mandrel, whereinadhering comprises adhering with a water-soluble tacking adhesive. Themandrel can be removed by dissolving the mandrel with water. Forming caninclude pressure-forming. (i.e., hydroforming with a fluid, even air).

The method can also include trimming the film. The thermoset film canhave one or more fibers or no fiber. The film can be substantiallyanisotropically mechanically load-bearing. For example, the load-bearingproperties of the film can be substantially unidirectional along thesurface plane of the film.

A method for making the device is disclosed that can include adheringwith a first bonding agent a first film to a mandrel, forming the firstfilm on about the first half of the mandrel, bonding with a secondbonding agent the first film to a second film, forming the second filmon about the second half of the mandrel, and dissolving the mandrel.Dissolving can include applying water to the mandrel. The first bondingagent can be water-soluble. The mandrel can be made from a sugar, aplastic, polylactic acid (PLA), polyvinylacetate, a water-soluble wax,or combinations thereof.

A method for making the device is disclosed that can include positioninga solid film on a mandrel and dissolving the mandrel with the solid filmon the mandrel. Dissolving can include dissolving with water. The filmcan be water-tight. The film can be configured as a flat piece of filmbefore forming on the mandrel. The film can have a square or rectangularshape before forming on the mandrel.

Also disclosed is a method for making the device that can includecreating a first hole that transects a mandrel, passing a fiber throughthe first hole, forming a layer of material on the mandrel, attachingthe layer to the fiber, and dissolving the mandrel. Attaching caninclude attaching the fiber to the side of the layer against themandrel, attaching the fiber to the side of the layer away from themandrel, attaching the fiber to the inside of the layer, or combinationsthereof.

A method for making the device is disclosed that can include applyingfibers to a mandrel, applying an elastomeric resin to the fibers andbonding the fibers to the mandrel. Applying the fibers can includerotating the mandrel while feeding the length of the fibers from alocation off the mandrel. The fibers or layer containing the fibers canbe bonded to the mandrel or to an adjacent layer to prevent the fibersfrom slipping against the mandrel or adjacent layer. The mandrel canhave an ovaloid shape.

A method for making the device is disclosed that can include applying afirst layer of a material on a water-soluble mandrel and forming athermoset film on the first layer. The method can be performed at atemperature from about 5 degrees Celsius to about 35 degrees Celsius,more narrowly from about 15° C. to about 30° C., for example at ambientor room temperature (e.g., about 18° C. to about 25.5° C.).

A method for making the device is disclosed that can include applying afirst layer of a material on a madrel, bonding with a first bondingagent a first thermoset film to the first layer, forming the firstthermoset film on about the first half of the first layer, bonding witha second bonding agent the first thermoset film to a second thermosetfilm, forming the second thermoset film on about the second half of thefirst layer, and dissolving the mandrel.

A method for making the device is disclosed that can include applying afirst layer of a material on a mandrel, hydroforming an MMA-resistantfilm on the first layer; and dissolving the mandrel with water.

A method for using the device is disclosed that can include insertingthe inflatable device adjacent to a target site, expanding theinflatable device to a pressure greater than about 350 kPa (51 psi), anddelivering to the target site thermal energy generated in the wall ofthe inflatable device. Delivering the energy can include singeing orablating tissue at the target site.

The balloon can be attached to a deployment tool having a deploymentrod. The deployment rod can have a rod distal end. The deployment rodcan be positioned at least partially inside the balloon when the balloonis in a deflated state. The deployment rod can be slidably adjustablewith respect to the location of the proximal end of the balloon. Thedeployment rod can be in an extended position when the balloon is in thesubstantially deflated state. The deployment rod can be in a retractedposition when the balloon is in the substantially inflated state. Therod distal end can be out of substantial contact with the balloon distalend when the balloon is in the substantially inflated state.

The rod distal end can be in contact with the balloon distal end whenthe balloon is in the substantially deflated state.

The deployment tool can have a fluid channel configured to deliver fluidto the balloon. When the deployment rod is in an extended position, thedeployment rod can substantially obstruct the fluid channel. When thewhen the deployment rod is in a retracted position, the deployment rodcan leave the fluid channel substantially unobstructed by the deploymentrod retracting the deployment rod with respect to the balloon, whereinretracting comprises substantially unobstructing fluid delivery throughthe fluid channel. Further comprising delivering fluid to the balloonafter retracting the deployment rod.

The deployment rod can be positioned at least partially inside theballoon when the balloon is in a deflated state. The deployment rod canbe fixed with respect to the location of the proximal end of theballoon. The rod distal end can be substantially separate (i.e., not insubstantial or any contact) with the balloon wall when the balloon is inthe substantially inflated state. The rod distal end can be atraumatic.The rod distal end can have a curved surface facing the balloon distalend. The deployment rod can be stiffer than the balloon when the balloonis in a contracted state.

A method for using the device is disclosed that can include inserting aworking channel through the biological body, delivering a first balloonthrough the working channel and positioning the first balloon at thetarget site. After the delivering the first balloon, the method caninclude delivering a second balloon through the working channel andpositioning the second balloon at the target site while the firstballoon is at the target site. The method can also include delivering anunsupported (i.e., in free air or about standard atmospheric pressure)pressure of greater than about 1400 kPa (200 psi) to the first and/orsecond balloon. The working channel can have an inner diameter less thanabout 5 mm. The working channel can have a distal port. The distal portcan be positioned adjacent to, or at, the target site, such as theinside of a vertebral body. The second balloon can be inflated after orconcurrent with inflating the first balloon.

The working channel can have an inner diameter less than about 5 mm. Thefirst and second balloons can be attached to separate first and seconddeployment systems, respectively, enabling independent orientationand/or translation of the first balloon from the second balloon, or thefirst and second balloons can be attached to a single integral jointdeployment system.

An inflatable device system is disclosed that can include a curved guideblock, a drill, a trocar, a first balloon, a steering mechanism, andcombinations thereof. A method for using the system can includepositioning a guide block outside of the biological body and deliveringa drill through the guide block. The method can include delivering thedevice through the guide block and into the biological body.

An inflatable device system is disclosed that can have a balloon, areservoir, a fluid in the reservoir; and a sealed sterile package. Theballoon, the reservoir and the fluid can be in the sealed sterilepackage.

An inflatable device kit is disclosed that can have a balloon having afully inflated state having an inflated volume, a fluid channel having afluid channel volume, a sealed reservoir, and a fluid in the reservoir.The fluid in the reservoir can have a fluid volume. The fluid volume canbe within 10% of the sum of the inflated volume and the fluid channelvolume.

A deployment tool for use with the inflatable device is disclosed thatcan have a fluid first channel having an incoming port. The fluid firstchannel can have a luer connector at the incoming port, a check valveand a swabbable valve. The swabbable valve can be adjacent to the luerconnector. The check valve can be downstream from the luer connector.

An assembly for use in percutaneously treating a bone predisposed tofracture or to collapse, or that is fractured or collapsed, isdisclosed. The assembly can have a cannula, a balloon, a catheter and adriving rod. The balloon can be insertable through the cannula intobone. The balloon can have a deflated condition which has a size forpassage through the cannula for insertion into bone. The balloon can beinflated to a predetermined shape and size sufficient for compressing atleast a portion of inner cancellous bone so as to form a cavity therein.The balloon can be restrained in the inflated condition to create saidpredetermined shape and size by having a wall that is thicker inselected portions than it is in other portions and/or by an internalrestraint provided in or on the balloon wall and/or by an externalrestraint in or on the balloon wall. The outer diameter of the cathetercan be smaller than the inner diameter of the cannula. The cannula canbe adapted to not drive the deflated balloon through the cannula intothe bone. The driving rod can releasably attach to the device. Thedriving rod can be adapted to drive the balloon through the cannula intothe bone.

The catheter can have an elastomer and a fiber. The driving rod can havea shaft and a clasp at the distal end of the shaft.

A method for using the device is disclosed that includes inserting aballoon into the target site, inflating the balloon and injecting a loadof bone cement into the target site. The load of bone cement can curewhile in contact with the balloon. The balloon does not substantiallydegrade from contact with the load of bone cement. The balloon can havea fiber made from a substantially different material than the remainderof the balloon. Inserting can include inserting with a detachabledriving rod. The method can include creating a void at the target site.

The balloon can be non-compliantly expanded. For example, the wall ofthe balloon can expand no more than about 2% to about 3% strain betweenthe deflated state to the inflated state.

The device can be used to perform valvulopasty, annuloplasty,kyphoplasty, sinuplasty or angioplasty procedures. The device can beused to minimally invasively deliver and expand a vascular stent, graftor heart valve. The device can be used to expand constrictions in theurethra. The device can be used to dilate CTOs. The device can be usedto temporarily or permanently occlude vessels, for example to isolate aspace within a vessel to locally deliver drugs or to intentionally causenecrosis. The device can be used to deliver therapeutic and/ordiagnostic drugs. The device can be used to deliver energy to warm,singe or ablate adjacent tissue. The device can be used as a radiopaqueor echogenic marker. The device can be used during a balloon enteroscopyprocedure or during colonoscopy. The device can be used to cut, tear, orotherwise rip tissue. The device can be implanted and inflated to createan anatomical feature, such as a breast implant.

BRIEF DESCRIPTION OF THE FIGURES

FIG. 1 illustrates a variation of the device.

FIG. 2 illustrates a variation of cross section A-A of FIG. 1.

FIGS. 3A through 3C are cross-sectional views of a length of variationsof the device.

FIG. 4A illustrates a variation of the device.

FIGS. 4B and 4C are variations of cross-section C-C of FIG. 4A.

FIG. 5A illustrates a variation of the device.

FIGS. 5B and 5C are variations of cross-section D-D of FIG. 5A.

FIG. 6A illustrates a variation of the device.

FIG. 6B is a variation of cross section E-E of the device of FIG. 6A.

FIG. 6C is a variation of cross section F-F of the device of FIG. 6A.

FIG. 6D is a variation of cross section G-G of the device of FIG. 6A.

FIGS. 7 and 8 illustrate variations of the device.

FIG. 9A illustrates a variation of the device in a deflated state.

FIG. 9B illustrates a variation of the device in an inflated state.

FIGS. 10A through 10D illustrate variations of the device.

FIGS. 11A and 11B illustrate partially see-through variations of thedevice.

FIGS. 11C through 11F are variations of cross-section H-H of FIG. 11A.

FIGS. 12 through 18 illustrate variations of the device.

FIG. 19A illustrates a variation of the device.

FIG. 19B is a variation of cross section i-i of FIG. 19A.

FIG. 20A illustrates a variation of the device.

FIG. 20B is a variation of cross section JJ of FIG. 19A.

FIGS. 21A and 21B are top and bottom perspective views, respectively, ofa variation of the device.

FIG. 22A illustrates a variation of the device.

FIG. 22B is a variation of cross-section K-K of FIG. 22A.

FIG. 23A illustrates a variation of the device.

FIGS. 23B and 23C are variations of cross-section L-L of FIG. 23A.

FIG. 24A illustrates a variation of the device.

FIG. 24B is a variation of cross-section M-M of FIG. 24A.

FIGS. 25 through 28 are cross-sectional views of variations of thedevice.

FIG. 29A illustrates a variation of the device.

FIG. 29B is a variation of cross-section N-N of FIG. 29A.

FIGS. 30A, 31A, 32A, 33A and 34A illustrate variations of the device.

FIGS. 30B and 30C; 31B; 32B; 33B; and 34B and 34C are variations ofcross-sectional views P-P through T-T respectively, of FIGS. 30A, 31A,32A, 33A, and 34A, respectively.

FIG. 35A illustrates a variation of the device.

FIG. 35B is a variation of cross-section U-U of FIG. 35A.

FIG. 36A illustrates a variation of the device.

FIG. 36B is a variation of cross-section V-V of FIG. 36A.

FIG. 37A illustrates a variation of the device.

FIG. 37B is a variation of cross-section W-W of FIG. 37A.

FIG. 38A illustrates a variation of the device.

FIGS. 38B, 38C and 38D are variations of cross-section X-X and Y-Y ofFIG. 238A.

FIG. 39A illustrates a variation of the device.

FIGS. 39B, 39C are variations of cross-section Z-Z and AA-AArespectively of FIG. 39A.

FIG. 40 illustrates a variation of the device.

FIGS. 41A and 41B illustrate a variation of the device in deflated andinflated configurations, respectively.

FIGS. 42A-42E are partial see-through views of variations of the device.

FIG. 43 illustrates a variation of an elongated element or strip.

FIG. 44 illustrates a variation of an element of the device.

FIG. 45 illustrates a variation of the device.

FIGS. 46A through 46O are sectional views through variations of crosssection BB-BB of FIG. 1.

FIGS. 47 through 49 are tables listing film materials, reinforcementmaterials, and adhesive and matrix materials, respectively.

FIG. 50 illustrates a variation of a tool for manufacturing a variationof the inflatable device.

FIG. 51 is a variation of cross-sectional view CC-CC of FIG. 50.

FIG. 52 is a chart of material characteristics for variations of mandrelmaterials.

FIGS. 53 through 58 illustrate a variation of a method for manufacturingthe device.

FIGS. 59A through 59H illustrate a method of making fiber tape.

FIGS. 60 through 67 illustrate a variation of a method for manufacturingthe device.

FIG. 68 illustrates a variation of a method for removing the mandrel.

FIG. 69 illustrates a variation of the device in an inflated statebefore being pleated.

FIG. 70 illustrates a method of adding pleats or folds to a variation ofthe device.

FIG. 71 illustrates a variation of the device in a deflated, pleatedstate.

FIG. 72 illustrates a portion of a method that may be used to produceunidirectional fiber tape.

FIG. 73 illustrates a portion of a method that may be used to produceunidirectional fiber tape.

FIGS. 74 through 77 illustrate variations of arrangements ofunidirectional fiber tape.

FIG. 78 illustrates a variation of a method for making a laminate.

FIG. 79 is a process flow chart of a variation of a process for making alaminate.

FIG. 80 is a graph illustrating a variation of temperature and pressureverse time graph for a method for compacting or curing or melting thatcan be used with a fiber tape.

FIG. 81A-81D illustrates a variation of the mandrel.

FIG. 82A illustrates a variation of a manufacturing tool.

FIG. 82B is a variation of cross-sectional view GG-GG of FIG. 82A.

FIG. 83 illustrates a variation of the fiber during a variation of amethod for manufacturing the device.

FIG. 84 is a variation of cross-sectional view GG-GG of FIG. 82A.

FIG. 85 illustrates a variation of the fiber during a variation of amethod for manufacturing the device.

FIG. 86 illustrates a variation of a method for manufacturing thedevice.

FIG. 87 illustrates a variation of the fiber during a variation of amethod for manufacturing the device.

FIG. 88 illustrates a variation of a method for manufacturing thedevice.

FIGS. 89 through 91D illustrate variations of a method for manufactureof the device.

FIGS. 92 through 94 illustrate variations of methods for manufacturingthe device.

FIGS. 95 through 100 illustrate variations of laminate sheets.

FIGS. 101 through 107 illustrate a method for manufacturing the device.

FIG. 108A illustrates a variation of a tool for manufacturing avariation of the inflatable device.

FIG. 108B is a variation of cross-sectional view II of FIG. 108A

FIGS. 109 through 115 illustrate a variation of a method formanufacturing the device.

FIGS. 116 through 119 illustrate a method for manufacturing the device.

FIG. 120 illustrates a variation of a layer.

FIGS. 121 and 122 illustrate variations of elongated elements.

FIGS. 123 and 124 illustrate variations of three overlayed elongatedelements.

FIGS. 125 though 127 illustrate variations of methods for manufacturingthe device.

FIG. 128A illustrates a variation of a manufacturing tool.

FIG. 128B is a variation of cross-sectional view LL-LL of FIG. 128A.

FIG. 128C is a close-up view MM-MM of FIG. 128B.

FIG. 129 is a partial see-through view of a sagittal view of a spine ina patient.

FIG. 130 is a partial see-through coronal view of a vertebra.

FIGS. 131, 134, 135, 137, 138, 139 and 140 are coronal cross-sectionalviews of a variation of a method of using a variation of the device in avertebra.

FIG. 132 illustrates a cross-section of a variation of the balloon wall.

FIG. 133 illustrates a cross-section of a variation of the ballooncontracted inside of the delivery tube.

FIG. 136 is a graph of compliance of the variation of the ballooncompared with a typical compliant balloon.

FIGS. 141A through 141 i are coronal cross-sectional views of avariation of a method of using a variation of the device in a vertebra.

FIGS. 142A through 142F are coronal cross-sectional views of a variationof a method of using a variation of the device in a vertebra.

FIGS. 143A through 143 i are coronal cross-sectional views of avariation of a method of using a variation of the device in a vertebra.

FIG. 144 illustrates a variation of the delivery guide block.

FIGS. 145 and 146 illustrate a variation of a method for using thedelivery guide block.

FIGS. 147 through 149 illustrate variations of a deployment tool withthe device.

FIG. 150A through 150C illustrate a variation of a method for using thedevice 2 and the deployment tool.

FIG. 151A illustrates a variation of the deployment tool.

FIG. 151B illustrates the proximal end of the variation of thedeployment tool during use.

FIG. 151C is a variation of cross-sectional view PP-PP of FIG. 151Ashown in a closed configuration.

FIG. 151D is a variation of cross-sectional view PP-PP of FIG. 151Ashown in an opened configuration.

FIG. 152A illustrates a variation of the deployment tool.

FIG. 152B illustrates the proximal end of the variation of thedeployment tool during use.

FIG. 152C is a variation of cross-sectional view QQ-QQ of FIG. 152Ashown in a closed configuration.

FIG. 152D is a variation of cross-sectional view QQ-QQ of FIG. 152Ashown in an opened configuration.

FIG. 153 is a variation of cross-sectional view A-A of FIG. 1

FIG. 154A illustrates a variation of the device with a component forinserting the device into the body.

FIG. 154B is a variation of cross-sectional view RR-RR of FIG. 154A.

FIG. 155A illustrates a variation of the device with a component forinserting the device into the body.

FIG. 155B is a variation of cross-sectional view SS-SS of FIG. 155B

FIG. 156 illustrates a variation of a system for using the device.

FIG. 157 illustrates a variation of the deployment rod.

FIGS. 158 and 159 illustrate a variation of a method for using thedevice.

FIG. 160 is a variation of cross-sectional view TT-TT of FIG. 159.

FIG. 161 is a variation of close-up of FIG. 160

FIG. 162 illustrates a variation of a method for using the device.

FIGS. 163A, 164A, 165A and 166A illustrate variations of the device.

FIGS. 163B, 164B, 165B and 166 b illustrate variations of the distalends of deployment or driving rods configured to interface with thedevices of FIGS. 163A, 164A, 165A and 166A respectively.

FIGS. 167, 168 and 169 illustrate sectional views of variations ofmethods for using a deployment or driving rod with the device.

FIG. 170 illustrates a variation of a method for using a deployment ordriving rod with the device.

FIG. 171A illustrates a variation of the shaft of the deployment rod.

FIGS. 171B through 171 i are variations of cross-section of FIG. 171A.

FIG. 172A illustrates a variation of a method for using a deployment ordriving rod with the device.

FIG. 172B is a variation of cross-sectional view UU-UU of FIG. 172A.

FIGS. 173A and 173B are cross sections of variations of methods ofdeployment.

FIG. 174A is a variation of a tool for inflating the inflatable device.

FIG. 174B is a variation of a sectional view of FIG. 174A.

FIGS. 175 through 177 illustrate variations of a kit including thedevice.

FIGS. 178 through 179F illustrate a variation of a method forvalvuloplasty.

FIGS. 180A through 180C illustrate a variation of a method forangioplasty.

DETAILED DESCRIPTION

FIG. 1 illustrates that a medical inflatable device 2 can have a balloon20 and a hollow shaft 2000. An inflation system (shown herein) can beattached to the hollow shaft to deliver a fluid pressure through thehollow shaft and to the balloon. The balloon can be resilient (i.e.,elastic) or non-compliant (i.e., inelastic). The balloon 20 can have aballoon longitudinal axis 26. The balloon 20 can have a balloon wall 22.The balloon wall 22 can define a cavity having a balloon volume 24.

FIG. 2 illustrates that the balloon 20 can have balloon length 28. Theballoon 20 can have a balloon proximal stem 30 having a balloon proximalstem length 32. The proximal stem length 32 can be from about 5 mm (0.2in.) to about 15 mm (0.6 in.). The balloon can have a balloon proximaltaper 34 having a balloon proximal taper length 36. The balloon proximaltaper length 36 can be from about 0 mm (0 in.) to about 20 mm (0.8 in.),more narrowly from about 0 mm (0 in.) to about 15 mm (0.6 in.), yet morenarrowly from about 5 mm (0.2 in.) to about 10 mm (0.4 in.) The balloon20 can have a constant-diameter section 38 having a constant-diametersection length 40. The constant-diameter section length 40 can be fromabout 0 mm (0 in.) to about 15 mm (0.6 in.), more narrowly from about 0mm (0 in.) to about 10 mm (0.4 in.). The balloon 20 can have a balloondistal taper 42 at the terminal distal end 68 or tip of the balloon 20.The distal taper 42 can have a distal taper length 44. The distal taperlength 44 can be from about 0 mm (0 in.) to about 14 mm (0.55 in.), morenarrowly from about 2 mm to about 9 mm.

The proximal and/or distal tapers 34 and/or 42 can have concave, convexand/or s-curves. For example, the proximal and/or distal tapers 34and/or 42 can have continuously varying angles with respect to theballoon longitudinal axis 26.

The balloon 20 can have a wall thickness 46. The wall thickness 46 canbe less than about 25 μm (0.98 mil). The wall thickness 46 can be fromabout 25 μm (0.98 mil) to about 250 μm (9.8 mil), more narrowly fromabout 50 μm (2 mil) to about 150 μm (5.9 mil), for example about 75 μm(3.0 mil) or about 100 m (4 mil).

The balloon can have a balloon inner diameter 48 and a balloon outerdiameter 50. The balloon outer diameter 50 can be measured perpendicularto the balloon longitudinal axis 26 at the widest point along the lengthof the balloon 20. The balloon outer diameter 50 can be from about 2 mm(0.08 in.) to about 50 mm (in.) for example about 17 mm (0.67 in.), 23mm (0.91 in.), 3 mm (0.12in.), or 6 mm (0.24 in.).

The balloon can have a radius (i.e., half the diameter), for exampleabout 8.5 mm, and a distal taper length, for example about 8.5 mm. Theratio of the distal end length to the radius can be from about 2:1 toabout 0:1, more preferably about 1:1 to about 0.25:1.

The balloon can have an unsupported burst pressure. The unsupportedburst pressure is the pressure at which the balloon ruptures wheninflated in free air without any external constraint on the walls atabout 1 atm external pressure and about 20° C. temperature. Theunsupported burst pressure can be greater than about 150 psi. Forexample, the unsupported burst pressure can be from about 1,400 kPa (200psi) to about 10,000 MPa (1,500 psi). More narrowly, the burst pressurecan be from about 3,500 kPa (500 psi) to about 6,000 kPa (900 psi). Forexample, the burst pressure can be about 3,500 kPa (500 psi), about5,200 kPa (750 psi), about 7,000 (1,000 psi), about 10,000 kPa (1,500psi), or higher than 10,000 kPa (1500 psi).

The balloon 20 can be non-compliant or inelastic. The balloon can have afailure strain of less than 0.30, more narrowly less than 0.20, morenarrowly less than 0.10, yet more narrowly less than 0.05. Anon-compliant balloon can have a failure strain of less than 0.30.

The failure strain of the balloon is the difference between the balloonouter diameter when the balloon is inflated to 100% of the burstpressure and the balloon outer diameter when the balloon is inflated to5% of the burst pressure (i.e., to expand from a deflated state withoutstretching the wall material) divided by the 100% pressure diameter.

For example, the burst pressure of the balloon can be greater than about3,500 kPa (500 psi) and have an outer diameter of about 17 mm and a wallthickness of less than about 100μm with a failure strain of less thanabout 0.10, for example less than about 0.05.

The reinforced balloon wall may have a high tear strength as compared totraditional polymers. Tear strength can correlate to puncture strengthand toughness. For example, in a Mod Mil-C-21189 10.2.4 tear test, aspecimen is created. That specimen has a width, a height, and thickness.A slit is made in the sample parallel to the width, mid-way along itsheight. The slit is then pulled to initiate tear at the corners of theslit. The Mod Mil-C-21189 10.2.4 tear test gives resultant data intensile pounds force (lbf). For the test to be meaningful as acomparison between two material samples, it should be done on athickness-comparable basis. A nylon 12 balloon material at about 0.0055in. thickness failed the test at a mean tensile load of 25 lbf. Theballoon wall 22 of about 0005 in. failed at a mean tensile value of 134lbf.

In an ASTM D-3039 tensile test, a nylon 12 material at 0.0055 in.thickness, failed at a mean tensile load of 22 lbf. The balloon wall 22of about 0.005 in. failed at a mean tensile value of 222 lbf.

The balloon wall 22 can have one or more layers 72. The balloon 20 canhave a leak-proof bladder 52. The bladder 52 can be fluid-tight, such asan air-tight, or saline tight, or a fluid porous bladder. The bladder 52can be made of a urethane, a nylon, any material listed infra, orcombinations thereof. The bladder 52 can be made from the radialinner-most layer 72 b of the balloon wall 22.

The bladder 52 can be fixedly or removably attached to the hollow shaft2000, for example at the inside and/or outside diameter of hollow shaft2000. The hollow shaft 2000 can be a flexible or rigid catheter. Thehollow shaft 2000 can deliver pressurized fluid to the balloon volume24.

The balloon 20 can have one or more balloon fluid ports 56. The hollowshaft 2000 can have a hollow shaft distal port 54. One of the balloonfluid ports 56 can attach to the hollow shaft distal port 54. Theballoon 20 (as shown in FIGS. 29A and 29B) can have a balloon fluidfirst port 56 a at a proximal end of the balloon 20 and a balloon fluidsecond port 56 b at a distal end of the balloon 20. The fluid first port56 a can be in fluid communication with the balloon fluid second port 56b via a through lumen and/or the balloon volume 24. The balloon 20 canhave a single balloon fluid port 56, two, three or more balloon fluidports 56. The balloon 20 can have no through lumen. For example, theballoon 20 can have no longitudinal through-lumen extending through theproximal terminal end 70 and through the distal terminal end 68.

FIGS. 3A, 3B and 3C show cross sections of a balloon wall 22. FIG. 3Aillustrates that a balloon 20 can have a constant or varying wallthicknesses 46 along the length of the balloon 20. A wall proximal stemthickness 46 a can be substantially equal to a wall constant diametersection thickness 46 c and the wall proximal taper thickness 46 b.

FIG. 3B illustrates that the wall constant diameter section thickness 46c can be substantially greater than the wall proximal stem thickness 46a. The wall proximal taper thickness 46 b can be less than the wallconstant diameter section thickness 46 c and greater than the wallproximal stem thickness 46 a.

FIG. 3C illustrates that the wall proximal stem thickness 46 a cansubstantially greater than the wall constant diameter section thickness46 c. The wall proximal taper thickness 46 b can be less than the wallproximal stem thickness 46 a and greater than the wall constant diametersection thickness 46 c.

FIG. 4A illustrates that the balloon 20 can have a single balloonexternal seam 66 a. The seam can extend partially, completely, or not atall through the depth of the wall thickness 46. The balloon externalseam 66 a can be a longitudinal seam. The balloon external seam 66 a canextend from a first lateral side of the balloon 20 at the proximalterminal end 70 of the balloon 20, along the first lateral side of theballoon to the balloon distal terminal end 68. The balloon external seam66 a can wrap around the balloon distal terminal end 68 a, extendingaround the distal end of the balloon 20 and returning on the secondlateral side of the balloon 20.

The outer layer 72 a of the balloon wall 22 can have an outer layerfirst panel 76 a and an outer layer second panel 76 b. The outer layerfirst panel 76 a can cover from about 90° to about 270° of the balloon,as measured along the balloon longitudinal axis 26, for example about185° of the balloon 20. The outer layer second panel 76 b can cover fromabout 90° to about 270°, as measured along the balloon longitudinal axis26, for example about 185°.

FIG. 4B illustrates that the balloon external seam 66 a can be anoverlayed seam or lap joint. The balloon external seam 66 a can be flushagainst the side (i.e., having a substantially constant radius withrespect to the balloon longitudinal axis 26) of the outer layer firstpanel 76 a or outer layer second panel 76 b. The outer layer first panel76 a can be radially outside of the outer layer second panel 76 b wherethe outer layer first panel 76 a overlaps the layer second panel 76 b.The outer panels 76 may have an overlap length. The overlap length canbe from about 0 mm (0 in.) to about 3 mm (0.1 in.), more narrowly fromabout 1 mm (0.04 in.) to about 2 mm (0.08 in.). The outer layer firstpanel 76 a can be bonded or adhered (e.g., with epoxy or other adhesive)to the outer layer second panel 76 b. The adhesive can be an epoxy.

The inner layer 72 b can have a balloon inner seam 66 b. The ballooninner seam 66 b can join an inner layer first panel 74 a and an innerlayer second panel 74 b. The inner seam 66 b can have a similarstructure to those described here for the balloon outer seam 66 a,

FIG. 4C illustrates that the outer layer first panel 76 a can be fused,solvated to, glued, adhered to, welded to, or a combination thereof,with the outer layer second panel 76 b at the outer seam 66 a.

FIG. 5A illustrates that the balloon external seam 66 a can be a flangejoint. The layer first panel can have a seam first flange 80 a aroundthe perimeter of the outer layer first panel 76 a. The outer layersecond panel 76 b can have a seam second flange 80 b around theperimeter of the layer second panel. The seam first flange can attach tothe seam second flange at the balloon external seam. The flange seam canextend radially away from the balloon longitudinal axis. The balloonexternal seam can be reinforced. The balloon external seam can be usedto cut tissue during use in a biological target site.

FIG. 5B illustrates that the seam first flange can be bonded or adheredto the seam second flange in the flange joint. FIG. 5C illustrates thatthe layer first panel can be fused, solvated to, glued, adhered to,welded to, or a combination thereof, with the layer second panel in theflange joint.

FIG. 6A illustrates that the balloon external seam 66 a can be a lateralor latitudinal seam. The balloon external seam can be in a planeperpendicular or substantially to the balloon longitudinal axis. Theballoon can have one or more balloon external seams.

The outer layer first panel 76 a can be at the distal end of the balloon20. The outer layer second panel 76 b can be at the proximal end of theballoon 20. The layer second panel can overlay the layer first panel atthe balloon external seam.

FIG. 6B illustrates that the outer layer first panel can overlay theouter layer second panel at the balloon external seam 66 a.

FIG. 6C illustrates that the balloon wall at a first length along theballoon can have a first layer and a second layer. The first layer canbe a radially inner layer 72 b, as measured from the balloonlongitudinal axis. The second layer can be a radially outer layer 72 a.Any of the layers 72 can be a laminate of fiber and resin. The resin canbe an adhesive. The fiber and resin laminate can be a matrix of thefiber in the resin.

FIG. 6D illustrates that the balloon wall at a second length along theballoon can have first, second and third layers. The second layer can bea first middle layer 72 c between the inner and outer layers. Anycombination of the layers can be leak-proof, reinforced with one or morefibers, resistant and releasable from MMA, or combinations thereof. Forexample, the first layer can be leak-proof and form the bladder. Thesecond layer can be reinforced with a fiber. The third layer can beMMA-resistant and/or MMA-releasing.

An MMA-resistant material can substantially maintain material strengthand thickness when exposed to MMA bone cement in any stage of the MMAbone cement from mixing to curing. An MMA-releasable material can formno substantial bond with MMA.

FIG. 7 illustrates that the balloon external seam can be along theballoon at the proximal taper. The balloon external seams can be in theconstant diameter section, the distal taper, the proximal taper, theproximal stem, or combinations thereof.

FIG. 8 illustrates that balloon external seam 66 b can lie in a plane ata non-perpendicular angle to the balloon longitudinal axis 26. The planein which the balloon external seam lies can form a seam angle 82 withthe balloon longitudinal axis. The seam angle 82 can be from about 0°(i.e., a longitudinal seam) to about 90° (i.e., a latitudinal seam).More narrowly, the seam angle 82 can be from about 30° to about 60°. Forexample, the seam angle 82 can be about 0°, about 30°, about 45°, about60°, or about 90°.

FIG. 9A illustrates that the balloon 10 can be pleated to form flutes84, for example four, five or six flutes 84, such as first flute 84 a,second flute 84 b. The flutes 84 can be made from accordion pleats, boxpleats, cartridge pleats, fluted pleats, honeycomb pleats, knife pleats,rolled pleats, or combinations thereof. The pleating can be heat and/orpressure formed and/or the reinforcement fibers and/or panels can beoriented to form the flutes 84. The balloon 20 can be in a deflatedconfiguration when the flutes 84 are shown.

FIG. 9B illustrates that the balloon 20 in an inflated configuration canpush the pleated flutes out to form a substantially smooth outersurface. The balloon 20 can have reinforcement fibers 86. First orlongitudinal reinforcement fibers 86 a can be parallel with the balloonlongitudinal axis 26. Second or latitudinal reinforcement fibers 86 bcan be perpendicular to the balloon longitudinal axis 26.

The proximal end of the balloon can be bonded, glued, welded to,adhered, clamped, fused, or combinations thereof to the distal end ofthe hollow shaft. For example, a balloon cuff can apply a tension forcebetween the proximal terminal end of the balloon and the distal end ofthe hollow shaft

FIG. 10A illustrates that the balloon can have a blunt distal terminalend. The distal terminal end can be rounded. The distal taper can have ataper angle 90 a measured from a perpendicular off the balloonlongitudinal axis. The taper angle can be from about 0° to about 80°,more narrowly from about 2° to about 45°, yet more narrowly from about5° to about 30°, for example about 0°, 10° or 15°.

FIG. 10B illustrates that the distal terminal end can be substantiallyflat. The taper angle of the balloon in FIG. 8B is lower than the taperangle of the balloon in FIG. 8A.

FIG. 10C illustrates that the distal terminal end can have facets. Thefacets can be angularly arranged around the balloon longitudinal axis.

FIG. 10D illustrates that the balloon distal terminal end can beconfigured to evert into the volume of the balloon. For example, theballoon distal terminal end can be hemi-toroidal, for example with aninner diameter of about 0 mm (0 in.).

FIG. 11A illustrates that the balloon can have a first and/or secondsteering wires 94 a and/or 94 b. The first and second steering wires 94a and 94 b can be evenly (about 180° apart) or unevenly (e.g., about 90°apart) spaced from each other with respect to the balloon longitudinalaxis. The balloon can have third and/or fourth steering wires (notshown) evenly spaced along the balloon wall between the first and secondsteering wires.

The first steering wire 94 a can be fixed to the balloon wall at a firstwire terminal 96 a. The second steering wire can be fixed to the balloonwall at a second wire terminal 96 b. The wire terminals 96 can belocated in the constant diameter section of the balloon, the proximaltaper, the distal taper, or a combination thereof. The first wireterminal 96 a can be located at the same or a different length along theballoon as the second wire terminal 96 b.

The steering wires 96 can be slidably translatable with respect to theballoon 20, for example except at the terminal ends. Forces can bedelivered to the steeling wires 96 to angularly rotate or deflect theballoon 20 with respect to an attached member, such as a deployment rodor the hollow shaft.

FIG. 11B illustrates that the balloon 20 can have a steering collar 98.The steering collar 98 can be rigid. The steering collar 98 can be ametal or plastic member embedded within or attached to the inside oroutside of the balloon wall. The steering collar 98 can be a reinforcedarea of the balloon wall, for example, reinforced with additionalreinforcement fibers. The wire terminals can be located on the steeringcollar. The steering wires can be fixed to the steering collar. Thefirst steering wire can be fixed to a first steering collar. The secondsteering wire can be fixed to a second steering collar.

The steering collar can be located in the constant diameter section ofthe balloon, the proximal taper, the distal taper, or a combinationthereof, for example if the balloon has the two or more steering collarsand/or the steering collar is at a non-perpendicular angle to theballoon longitudinal axis.

FIG. 11C illustrates that the balloon can have a steering sheath 100.The steering wire 94 can slide within the steering sheath. The steeringsheath 100 can be radially inside, radially outside, or embedded within(as shown) the balloon wall 22. The steering sheath 100 can be made froma low friction material and/or be coated with a low friction material,such as PTFE or Teflon.

FIG. 11D illustrates that the steering wire 94 can be located in theballoon wall 22, for example between the inner and outer layers 72 b and72 a of the balloon wall 22. The balloon wall 22 can have no steeringsheath or the steering sheath can end at a length before the wireterminal 98.

FIG. 11E illustrates that the steering wire can be on the outside of theballoon wall, opposite of the balloon volume. FIG. 11F illustrates thatthe steering wire can be on the inside of the balloon wall, within theballoon volume.

FIG. 12 illustrates that the proximal stem, proximal taper, constantdiameter section, distal taper, or combinations thereof can be curved.The balloon longitudinal axis can be straight or have a balloon radiusof curvature 102. The balloon radius of curvature 102 can be from about2 to about 50 mm, for example about 5 mm, about 8 mm, or about 30 mm.

FIG. 13 illustrates that the balloon can have a C-shaped configuration.For example, the balloon radius of curvature can be from about 5 mm toabout 40 mm for example about 15 mm

FIG. 14 illustrates that the balloon can bifurcate into a first balloonbranch 106 a and a second balloon branch 106 b. The first balloon branch106 a, second balloon branch 106 b and proximal stem 30 can be coplanar(as shown) or not coplanar. Third, fourth or more balloon branches canextend from the proximal stem. The balloon branches 106 can be in fluidcommunication with the proximal stem 30 and other balloon branches Theballoon branches 106 can be inflated and deflated concurrently. Theballoon branches 106 can be in fluid isolation from the other balloonbranches 106. The balloon branches 106 can be inflated and deflatedsubsequent to the other balloon branches 106.

The proximal stem 30 can have a proximal stem longitudinal axis 110. Theballoon first branch 106 a and the balloon second branch 106 b can beevenly separated (by about 180°) or unevenly separated (e.g., by about90°) with respect to the proximal stem axis 110.

The balloon first branch 106 a can have a first branch longitudinal axis108 a. The first branch longitudinal axis 108 a can be straight orcurved. The balloon second branch 106 b can have a second branchlongitudinal axis 108 b. The second branch longitudinal axis 108 b canbe straight or curved. The balloon first branch 106 a can have the same,the symmetric, or a different shape as the balloon second branch 106 b.The balloon branches 106 can have symmetric c-shapes (as shown).

The balloon first branch 106 a can have a balloon first distal terminalend 68 a. The balloon second branch 106 b can have a balloon seconddistal terminal end 68 b. The balloon 20 can have a terminal end gap 104between the first distal terminal end 68 a and the second distalterminal end 68 b.

The balloon wall can have a pressure input port in fluid communicationwith a pressure channel embedded in or attached to the outside or insideof the wall of the balloon. The port can be for inflating the balloon.The pressure can be delivered to the inner lumen 154 a. The pressure canbe and is conveyed with water.

The balloon wall can have a bone cement input port 114 a. The bonecement input port 114 a can be in fluid communication with a bone cementchannel embedded in or attached to the outside or inside of the balloonwall 22, or as an outer lumen 154 b (shown supra) within the balloon 20.

The balloon first and/or second branch can have one or more bone cementoutput ports 114 b. The bone cement channel can be in fluidcommunication with the bone cement output ports 114 b. The bone cementoutput ports can open to a contained area 112 defined by the firstballoon branch and the second balloon branch. The bone cement outputports can open away from the contained area 112. The bone cement can bea bone cement or one or more liquid, gel or solid bone fillers with nocement properties.

FIG. 15 illustrates that the balloon can have a substantially toroidalconfiguration. For example, the balloon can have no balloon terminaldistal end. The proximal stem can attach to a toroidal constant diametersection. The toroid can define a circular contained area 112.

FIG. 16 illustrates that the balloon can have a substantiallycylindrical configuration. The balloon can have a balloon top 116,balloon bottom 118 and a balloon pressure input port 56. Duringinflation, the balloon 20 can expand in the vertical direction. Theballoon 20 can be folded in a contracted or deflated configuration. Theratio of balloon height 120 to balloon width 120 can be 1:3. Forexample, the balloon can form a disc. The ratio of balloon height 120 toballoon width 120 can be 1:1, for example the balloon can expandsignificantly in height during expansion. The balloon top 116 can beparallel to the balloon bottom 118. The balloon top 116 can be flat ortilted at about 10°, about 20°, or about 30° relative to the balloonbottom 118.

FIG. 17 illustrates that the balloon 20 can have balloon first, second,third and fourth segments 124 a, 124 b, 124 c, and 124 d. The balloonsegments 124 can have cylindrical configurations. The balloon segments124 can have segment sides 129, segment tops 126 and segment bottoms128. The balloon segments 124 can be attached to the adjacent segmentsat the segment sides 129. The balloon segments 124 can be in fluidcommunication with each other and the proximal stem, for example by acommon inflation lumen, or separately in fluid communication withproximal stem. The segments can be inflated concurrently, incombinations (e.g., the first and fourth segments concurrently, then thethird and second segments), or sequentially.

The proximal stem shown herein can be substituted in variations for thehollow shaft and the hollow shaft can be substituted in variations forthe proximal stem.

FIG. 18 illustrates that the balloon can have anisotropic compliance orelasticity characteristics across the balloon wall 22. For example, theballoon 20 can be less compliant or substantially non-compliant parallelto the balloon longitudinal axis, and more compliant perpendicular tothe longitudinal axis.

The balloon wall 22 can have a first unidirectional fiber-reinforcedlaminate 130 a oriented at a fiber angle 132 of about 15° relative toballoon the balloon longitudinal axis. The balloon wall 22 can have asecond unidirectional fiber-reinforced laminate 130 b oriented at afiber angle 132 of about −15° relative to the balloon longitudinal axis.As the pressure inside the balloon increases, the diameter of theballoon adjacent to the balloon longitudinal axis can be substantiallyconstant. As the pressure inside the balloon increases, the diameter ofthe balloon perpendicular to the longitudinal axis can substantiallyincrease.

FIGS. 19A and 19B illustrate that the balloon can have a peanutconfiguration, like the balloon configuration shown in FIGS. H and H′.

FIGS. 20A and 20B illustrate that a first balloon 20 a can be bonded toa second balloon 20 b. The first balloon 20 a can be bonded to thesecond balloon 20 b, for example along a bonded surface 138. The bondedsurface 138 can be parallel with the balloon longitudinal axis.

FIGS. 21A and 21B illustrate that the balloon 20 can have a flat balloontop and/or flat balloon bottom 116 and/or 118. The balloon 20 can applya uniform force across the balloon top and/or bottom 116 and/or 118 tothe endplates of the vertebrae.

The balloon 20 can be shaped to follow the contours of the vertebralbody. The balloon 20 can have a first lateral side 117 a and a secondlateral side 117 b. The first lateral side 117 a can have an innerradius of curvature. The second lateral side 117 b can have an outerradius of curvature. The inner radius of curvature can be from about 5mm to about 30 mm for example about 15 mm. The outer radius of curvaturecan be from about 5 mm to about 30 mm for example about 20 mm.

The inner radius of curvature side can face the posterior of thevertebral body. The outer radius of curvature side can face the anteriorof the vertebral body.

FIGS. 22A and 22B illustrate that the balloon can have a substantiallycylindrical configuration and that the balloon top and/or balloon bottomcan curve when the balloon is in an expanded or inflated configuration.The balloon top can have a balloon top radius of curvature 140. Theballoon bottom can have a balloon bottom radius of curvature 142. Theballoon top radius of curvature 140 can be substantially equal to ordifferent from the balloon bottom radius of curvature 142. The balloontop and/or balloon bottom can be reinforced, for example altering therespective radius of curvature. The balloon top or bottom radius ofcurvature 140 or 142 can be from about 250 mm to about 30 mm for exampleabout 60 mm.

FIG. 23A illustrates that the balloon can have a cylindricalconfiguration oriented with the flat balloon top and flat balloon bottomfacing parallel with the balloon longitudinal axis.

FIG. 23B illustrates that the balloon top and/or balloon bottom can bereinforced. For example, the balloon top and/or bottom can have vanes,hard plastic or metal (e.g., tantalum) discs, one, two or more layers oflaminate compared to the wall of the balloon side, or combinationsthereof.

FIG. 23C illustrates that one, two or more internal restraints 144 canbe oriented longitudinally within the balloon. For example, the internalrestraints 144 can be fixed to the balloon top and the balloon bottom.

FIG. 24A illustrates that the balloon can have a cube orthree-dimensional rectangular configuration. The balloon can have sixsubstantially flat balloon faces 146. The balloon faces 146 can beoriented at a right angle to the adjacent balloon faces 146. The balloon20 can have a balloon edge 148 between adjacent faces.

FIG. 24B illustrates that the balloon 20 can have a one or more firstinternal restraints 144 a. The first internal restraints 144 a can benon-compliant fibers or wires fixed to opposing balloon faces. The firstinternal restraints 144 a can be oriented vertically or latitudinallywithin the balloon. The balloon can have one or more second internalrestraints 144 b. The second internal restraints 144 b can be orientedperpendicular to the first internal restraints 144 a. The secondinternal restraints 144 b can be oriented laterally or latitudinallywithin the balloon. The balloon can have one or more third internalrestraints (not shown). The third internal restraints can be orientedperpendicular to the first and second internal restraints. The thirdinternal restraints can be oriented longitudinally within the balloon.The restraints 144 can terminate on in the inside surface of the balloonwall 22, within the balloon wall 22 or on the outside of the balloonwall 22 (not shown).

FIG. 25 illustrates that a first balloon 20 a can be inflated though thefirst pressure inlet port 56. A second balloon 20 b can surround thefirst balloon 20 a. The second balloon 20 b can be inflated though asecond pressure inlet port 58. The first balloon 20 a and the secondballoon 20 b can have different shapes when inflated. The first balloon30 a and the second balloon 30 b may be inflated independently during amedical procedure. The first balloon 30 a can be used to create aninitial lumen in the body. The second balloon 30 b can be used to shapeor expand the initial lumen in the body.

FIG. 26 illustrates that a first balloon 30 a can be inflated though thefirst pressure inlet port 56 a. The second balloon 30 b can surround thefirst balloon 30 a. The second balloon 20 b can be separated from thefirst balloon 20 a by an inter-balloon gap 150. The second balloon 20 bcan be in contact with the first balloon 20 a (i.e., the inter-balloongap 150 can be 0). The second balloon 30 b can be inflated though thesecond pressure inlet port 58. The first balloon 20 a and the secondballoon 20 b can have different shapes when inflated. The first balloon20 a and the second balloon 20 b may be inflated independently during amedical procedure. The second balloon 20 b can have holes in the balloonwall that leak inflation material during an inflation cycle. The secondballoon 20 b can be biocompatible. The inflation material can be bonecement. The bone cement can cure and leave the second balloon 20 bimplanted in the body. The first balloon 20 a may be deflated andwithdrawn before the bone cement cures.

FIG. 27 illustrates that the balloon 20 can extend from a lateral sideof the hollow shaft 2000.

FIG. 28 illustrates that the balloons 20 can inflate from one lateralside of the hollow shaft 2000. Pressure is provided into the inflationlumen from the proximal end of the hollow shaft 2000. The balloons 20may be of the same or different shapes. There may be two balloons 20attached to the hollow shaft 2000. There may be four balloons attachedto the hollow shaft 2000.

FIGS. 29A and 29B illustrate that the balloon 20 can have a balloonfirst fluid port 56 a at a first end and a balloon fluid second 56 bport at a second end. The balloon 20 can have a distal stem 152 and aproximal stem. The balloon can have a longitudinal through lumen. Thedistal taper angle can be from about 0 to about 90°, more narrowly about40° to about 15°, yet more narrowly about 30° to about 10°, for exampleabout 22°. The proximal taper angle 90 b can be from about 0 to about90°, more narrowly about 40° to about 15°, yet more narrowly about 30°to about 10°, for example about 22°. The distal blunting angle 92 can befrom about 0 to about 90°, more narrowly about 50° to about 85°, yetmore narrowly about 60° to about 80°, for example about 68°. The distalblunting angle 92 can be about equivalent to the distal taper angle 90b.

FIGS. 30A and 30B illustrate that the balloon 20 can have a firstsegment 124 a and a second segment 124 b. The first segment 124 a andthe second segment 124 b can be longitudinally concurrent. The distalend of the balloon wall can be attached to the distal end of the hollowshaft 2000 so the balloon wall 22 extends from the proximal side of theattachment.

FIG. 30C illustrates that the distal end of the balloon can beconfigured to extend distally past the attachment of the balloon to thehollow shaft, for example past the distal end of the hollow shaft. Theshaft defining the inner lumen can translate in the longitudinaldirection with respect to the hollow shaft 2000.

FIGS. 31A and 31B illustrates that the distal end of the balloon wallcan be attached to the distal end of the hollow shaft so the balloonwall extends from the distal side of the attachment.

FIGS. 32A and 32B illustrates that the distal end of the balloon wallcan be attached to the distal end of the hollow shaft so the balloonwall extends from the distal side of the attachment. The proximalterminal end of the balloon can overhang the outer hollow shaft.

FIGS. 33A and 33B illustrate that from the proximal end to the distalend, the balloon can have a proximal taper, a first step 134 a, a firststep taper, a second step 134 b, a second step taper, a third step 134c, and a distal taper, or combinations thereof. The first step 134 a canhave a first step radius 136 a. The second step 134 b can have a secondstep radius 136 b. The third step 134 c can have a third step radius 136c. The first step radius 136 a can be greater than or less than (asshown) the second step radius 136 b. The second step radius 136 b can begreater than or less than (as shown) the third step radius 136 c. Thefirst step radius 136 a can be greater than or less than (as shown) thethird step radius 136 c.

During use, the increasing radii steps can be used to measure the targetsite and use the best size of balloon without having to remove theballoon from the patient and delivering a second balloon to the targetsite. For example, the balloon can sequentially dilate a stenotic vesselor valve with increasing known radii (e.g., instead of purely by feel)of dilation.

FIGS. 34A and 34B illustrate that the first step radius and the thirdstep radius can be substantially equal. The second step radius can beless than the first step radius and the third step radius.

FIG. 34C illustrates that a radially expandable implant 156 can beremovably attached to the balloon wall 22. For example, a stent, apercutaneous aortic heart valve, a replacement heart valve annulus, orcombinations thereof, can be balloon-expandable and deformed into thesecond step before insertion of the balloon into the target site.

FIG. 35A illustrates that an inflation device can have a first balloon20 a and a second balloon 20 b. The second balloon 20 b can belongitudinally distal to the first balloon 20 a. The first balloon canbe directly attached to the second balloon. The first balloon 20 a canbe attached to a proximal end of a balloon joint 158. The second balloon20 b can be attached to a distal end of the balloon joint 158.

The first balloon can be in fluid communication with the second balloon.The first balloon can be inflated and/or deflated concurrent with thesecond balloon. The first balloon can be in fluid isolation from thesecond balloon. The first balloon can be inflated and/or deflatedprecedent or subsequent to the second balloon's inflation or deflation.

The distal terminal end of the second balloon 20 b can have a balloonsecond fluid port 56 b. The balloon second fluid port 56 b can be influid communication with the hollow shaft 2000 and/or the first and/orsecond balloons 20 a and/or 20 b.

FIG. 35B illustrates that the fluid port can be in fluid communicationwith an inner lumen. The inner lumen and balloon second fluid port canbe made of a material that does not bond to or degrade by exposure tocommon bone cements, such as methyl methacrylate. A middle lumen 154 ccan be in fluid communication with the interior of the second balloon 20b. The middle lumen 154 c can inflate the second balloon 20 b.

The outer lumen 154 b can be in fluid communication with the interior ofthe first balloon 20 a. The outer lumen 154 b, can inflate the firstballoon 20 a. Various pumps, syringes or pressure sources (not shown),or combinations thereof; can attach and deliver fluid pressure to theinner, middle or outer lumens 154 a, 154 c, 154 b.

The device 2 can be inserted into a structure in the body. The structurecan be bone. As described herein, the first and second balloons 20 a and20 b can be inflated to create a balloon void in the body structure. Oneof the balloons 20 can be deflated and left in the body. An adhesive,(for instance, bone cement) can be injected though the inner lumen 154 aand emerge from the balloon second fluid port 56 b into the balloon voidcreated in the body. The adhesive can fill or partly fill the portion ofthe balloon void created by the just-deflated balloon. The adhesive cancure while the other balloon remains inflated. The remaining balloon canthen be deflated and the inflation system withdrawn. Adhesive can beinjected to fill or partially fill the lumen created in the bodystructure by the inflation system. More than two balloons (e.g., threeor four) can be used with the inflation system.

FIGS. 36A and 36B illustrate that the balloon 20 can have a toroidal orannular shape. A fluid conduit 176 can extend from the hollow shaft 2000to the balloon 20. The fluid conduit 176 can delivery fluid pressure toinflate and deflate the balloon 20. The balloon 20 can have an innerwall 22 a and an outer wall 22 b. The inner wall 22 a can be radiallyinside the outer wall 22 b. The balloon 20 can have an annular lumen 160passing through the radial center of the balloon 20. The annular lumen160 can open to an annular lumen distal port 162 a and an annular lumenproximal port 162 b.

The distal end of the annular lumen 160 can be attached to one or moredistal tensioners 164 a. The distal-tensioners 164 a can be elastic orinelastic wires, fibers or threads. The distal tensioners 164 a can befixed at distal tensioner first ends evenly or unevenly angularlydistributed around the distal end of the balloon 20. The distaltensioners 164 a can attach at distal tensioner second ends to a distaltension anchoring wrap 166 a. The distal tension anchoring wrap 166 acan be fixed to the hollow shaft 2000.

The proximal end of the annular lumen 160 can be attached to one or moreproximal tensioners 164 b. The proximal tensioners 164 b can be elasticor inelastic wires, fibers or threads. The proximal tensioners 164 b canbe fixed at proximal tensioner first ends evenly or unevenly angularlydistributed around the proximal end of the balloon. The proximaltensioners 164 b can attach at proximal tensioner second ends to aproximal tension anchoring wrap 166 b. The proximal tension anchoringwrap 166 b can be fixed to a tensioning collar 168.

The second step can form a waist. The waist can have additional hoopwrapped fibers. The waist can be substantially non-compliant. The waistcan be from about 0 mm to about 12 mm in the balloon longitudinaldirection, more narrowly from about 3 mm to about 9 mm. The waistdiameter can be from about 2 mm to about 35 mm, for example about 3 mm,about 6 mm, about 20 mm, or about 23 mm.

The tensioning collar 168 can be slidably attached to the hollow shaft2000. The tensioning collar 168 can translate longitudinally, as shownby arrows in FIG. 36B, along the shaft. The tensioning collar can bepulled and/or pushed by a control line 170 or rod. Before deployment ofthe inflatable device and alter deployment but before removal of theinflatable device, the balloon can be deflated and contracted againstthe hollow shaft. For example, the control line can be pulled to retractthe proximal end of the balloon. For example, the balloon can fold andcontract against the hollow shaft. The balloon may be pleated such that,when the tensioning collar is pulled or when a vacuum is applied tot theinflatable device, the balloon contracts into a small, packed form (notshown).

The balloon can have a distal segment 172 a and a proximal segment 172b. The distal segment 172 a and the proximal segment 172 b can beannular or toroidal. The annular or toroidal planes can be perpendicularto the balloon longitudinal axis 26. The distal segment 172 a can belongitudinally adjacent to the proximal segment 172 b. The distalsegment 172 a can be directly bonded to the proximal segment 172 b orjoined to the proximal segment 172 b by a segment joint 174. The segmentjoint 174 can be open and allow fluid communication between the proximalsegment 172 b and the distal segment 172 a (not shown) or can be closedto isolate the fluid volume or the proximal segment 172 b from the fluidvolume of the distal segment 172 a.

The distal segment and/or the proximal segment may be inflated by atube. The tube may be attached to the hollow shaft.

The outer wall, the inner wall, or both walls, may contain a radiopaquematerial as described herein.

The outer wall of the distal segment can form the first step. Thesegment joint can form the second step. The outer wall of the proximalsegment can form the third step. The second step can be radially smallerthan the first step and the second step. A device, such as a minimallyinvasive replacement heart valve can be attached to the outside of theballoon.

FIGS. 37A and 37B illustrate that the device (shown in 36A and 36B) canhave a valve 178. The valve 178 can have a first leaflet 180 a, a secondleaflet 180 b, a third leaflet (not shown), or more. The leaflets 180can be thin and flexible. The leaflets 180 can collapse inside theannular lumen when the balloon is in a contracted configuration. Thevalve can allow flow through the annular lumen 160 in the distaldirection and prevent flow through the annular lumen 160 in the proximaldirection. The valve 178 can be fixed to the distal end of the distalsegment of the balloon. The leaflets 180 can be oriented to allow flowdistally through the annular lumen and impede or prevent flow proximallythrough the annular lumen. The leaflets 180 can be oriented to allowflow proximally through the annular lumen and impede or prevent flowdistally through the annular lumen.

FIG. 38A illustrates that the balloon can have segments that can beangularly adjacent to each other. For example, the segments and thesegment joints can be parallel with the longitudinal axis. The secondstep can have a larger radius than the first step or the third step. Theproximal and distal tensioners can attach to the segments and/or segmentjoints.

The segments may be inflated by a tube. The tube may be attached to thehollow shaft 2000. The distal and/or proximal tensioners can attach tothe balloon at the segment joints and/or at the segments.

The segment walls can have a radiopaque foil and/or a wire, such as aradiopaque marker wire.

FIG. 38B illustrates that the segments can be in fluid isolation fromeach other at the length along the balloon shown in FIG. M1. Thesegments can have a flattened circle longitudinal cross-sectionalconfiguration. For example, the segments can be almond or eye-shaped.

FIG. 38C illustrates that the segments can be in fluid communicationwith each other at a length along the balloon shown in FIG. M1.

FIG. 38D illustrates that the segments can have a circular longitudinalcross-sectional configuration. For example, the segments can becylindrical.

FIGS. 39A and 39B illustrate that the balloon can have a constant outerdiameter when measured along the longitudinal axis nope, it won't quitedo that. For example, the balloon can have a single step. The ballooncan have an inner wall 22 a, an outer wall 22 b and segment joints 174.The segment joints 174 can connect the inner wall to the outer wall. Thesegment joints 174 can minimize the inward radial collapse of the innerwall during inflation.

FIG. 39C illustrates that the hollow shaft can have an inner lumen 154 aand an outer lumen 154 b. The fluid conduit can be in fluidcommunication with the outer lumen and the balloon. The outer lumen candeliver pressure through the fluid conduit and to the balloon. The innerlumen can be a through lumen. The outer lumen can extend through thedistal proximal tip.

FIG. 40 illustrates that the balloon can have a spiral or helicalconfiguration. The spiral can have a first winding 182 a, a secondwinding 182 b, and more (e.g., five, as shown) windings. The firstwinding 182 a can be joined to the second winding 182 b at a windingjoint 184. The winding joint 184 can have an adhesive or a weld joint.The winding joint 184 can have a strip of elastic or inelastic materialattached to the adjacent windings. The balloon 20 can be formed from asingle continuous lumen.

FIG. 41A illustrates that the first flute can have a first vane 186 a.The second flute can have a second vane 186 b. The vanes 186 can beembedded within or attached to the inside or outside of the balloon wall22. All, some, one, or none of the flutes can have vanes. The vanes 186can be reinforcements. For example, the vanes 186 can be a laminate,foil or wafer. The foil or wafer can be a plastic or metal listedherein, such as tantalum. The vane 186 can be strong enough to cut softor hard tissue adjacent to the pleat. The vanes 186 can be rigid orflexible.

FIG. 41B illustrates that in an inflated or expanded configuration, thevanes 186 can lie flat along the wall.

A single radiopaque layer can encompass substantially the entire area ofthe balloon (as shown in FIG. 1, but with a radiopaque layer congruentwith the balloon 20). The radiopaque layer can be a tantalum or othermetal foil selected from a radiopaque metal such as those listed herein.The radiopaque layer can be a single continuous layer, for example as adeposition or foil lining with e.g. a deposition or foil of a metal suchas tantalum. FIG. 42A illustrates that the balloon can have vanes can bespaced evenly around the balloon longitudinal axis. The vanes can beradiopaque and/or echogenic. The vanes can be rectangular, triangular,circular, oval, or combinations thereof. The vanes can be oblong havinga major axis and a minor axis. The major axis can be parallel with theballoon longitudinal axis.

FIG. 42B illustrates that the balloon can have first vanes spaced evenlyaround the balloon longitudinal axis. The balloon can have one or moresecond vanes at the balloon distal terminal end.

FIG. 42C illustrates that the balloon can have a third vane at theproximal taper. The second and/or third vanes can partially orcompletely circumferentially envelope the balloon around the balloonlongitudinal axis.

FIG. 42D illustrates that the balloon can have marker spots 188 evenlyor unevenly distributed around the balloon. The marker spots 188 can beradiopaque and/or echogenic. The marker spots 188 can be circular, oval,square, triangular, rectangular, pentagonal, hexagonal, or combinationsthereof. The marker spots 188 can be in a layer of the balloon wall orattached to the inner or outer surface of the balloon wall.

42E illustrates that the balloon can have a marker wire 190 in a helicalconfiguration about the balloon longitudinal axis. The marker wire 190can be radiopaque and/or echogenic. The wires 190 can be electricallyconductive. The wires 190 can carry electrical current, for example forRF delivery, resistive heating, or combinations thereof. The marker wire190 can be in a layer of the balloon wall or attached to the inner orouter surface of the balloon wall 22.

The marker wire 190 can carry a tensile load. For example, the wire canhave a 0.001 in. diameter and maintain a tensile load of 0.3 N withoutyield or failure. The wire can be gold.

The marker wire 190 or another configuration of a panel or wire, such asshown in FIG. 45, can be a resistive heating or RF element. The systemcan have a power supply for delivering energy, such as electricalcurrent, to the resistive heating element. The system can have a heatcontrol unit for controlling the level of energy delivery to theresistive heating element. The heating element can be separated positiveand negative electrodes on the balloon wall outer surface and contactthe target site tissue directly, within the balloon wall, or on theradial inside of the inside surface of the balloon, or combinationsthereof. The heating element can have a dielectric material.Radiofrequency energy can be delivered across the dielectric material ofthe heating element to create ohmic heating in the tissue.

The vanes 186, the marker spots 188 and the wires 190 can be on theinside of the balloon wall 22, the outside of the balloon wall 22, orwithin the balloon wall 22.

FIG. 43 illustrates a panel 196 that can be configured as an elongatedmember or strip 192 that can be placed in a layer of the balloon wall.The strip 192 can have a strip longitudinal axis 194. The strip 192 canhave one or more reinforcement fibers, for example, parallel and/orperpendicular with the strip longitudinal axis 194. The strip can haveone or more vanes. For example, the strip can have multiple rows ofvanes.

FIG. 44 illustrates a panel can have one, two, three, four, five, six(as shown) or more panel arms 200, such as panel first arm 200 a andpanel second arm 200 b. The 196 panel can be a rosette. The panel 196can have a panel center 198. The panel aims 200 can extend from thepanel center 198. The panel arms 200 can have arm longitudinal axes. Theangle between adjacent arm longitudinal axes can be arm angles 202.

The panel or radiopaque foil pattern can have panel arms that can befolded over a balloon 20 during manufacture such that radiopaque foilpanel can be embedded within the balloon wall 22. The radiopaque foiland any other radiopaque or metal element herein can be made from gold,platinum, platinum-iridium alloy, tantalum, palladium, bismuth, barium,tungsten, or combinations thereof. Any of the layers can have particlesof gold, platinum, platinum-iridium alloy, tantalum, palladium, bismuth,barium, tungsten or combinations thereof. Any of the layers can haveradiopaque dyes.

The foil can be less than about 30 μm thick, for example less than about20 μm thick, for example about 15 μm, about 12 μm, about 10 μm or about8 μm thick. Radiopaque foils can be cut or patterned by laser cutting,wire EDM, die cutting or deposition. The foils may be mounted to aremovable backing before cutting such that a pattern of foils may beeasily applied during the balloon construction process.

The panels and/or vanes can cover the distal half of the balloon. Thepanels and/or vanes can cover the proximal half of the balloon. Thepanels and/or vanes can overlap in the longitudinal center of theballoon.

The panel, such as a foil, can be located in the balloon wall 22 in anarea that is exposed to increased stresses during inflation. Aradiopaque foil can strengthen the balloon wall 22.

The balloon 20 can have pleats or flutes between vanes or panels. Thevanes or panels can form the pleats or flutes. A panel or vane, such asa radiopaque foil, can minimize leaks from forming between fibers in theballoon during use.

FIG. 45 illustrates that the balloon can have a resistive heatingelement 204 in a layer of the balloon wall or on the radial outside orradial inside of the balloon wall. The heating element 204 can have aresistive wire on a panel. The panel can be made from copper or anothermetal. The heating element 204, such as the resistive wire or panel, canbe connected to a heating lead 206. The heating lead 206 can extendproximally along the hollow shaft 2000. The heating lead 206 can beproximally connected to a controller and power source. The balloon 20can be used to heat, cool (e.g., when the panel is a Peltier junction),emit RF power, or combinations thereof.

The heating element can be substituted for or configured in combinationwith a UV-emitting element, visible light-emitting element,microwave-emitting element, ultrasonic-emitting element, or combinationsthereof. The heating element 204 can be replaced or configured with astrain gauge, a peltier junction or a temperature measuring device, orcombinations thereof.

The balloon can be used to treat abnormal mucosa in an esophagus, forexample by positioning the heating element near or in contact with theabnormal mucosa and delivering heat. The mucosal layer of the esophagealwall, for example the columnar epithelium, can be injured or ablated andmade necrotic with the balloon to normalize mucosa in the esophagus.

FIG. 46A illustrates that the balloon wall 22 at section BB-BB or atother sections taken through a single wall of the balloon can have alayer 72 that can have a fiber tape matrix. The fiber tape matrix canhave one or more reinforcement fibers 86 and one or more resins. Theresin can be a flexible adhesive 208. The flexible adhesive can remainflexible when cured or melted to form the medical inflatable device 2.

The fiber tape (also referred to as unidirectional fiber reinforcedtape, unidirectional tape, and uni-tape) may have one, two or moremonofilaments 86 running substantially parallel to each other andembedded in a flexible adhesive 208. Uni-tape may be produced with aremovable backing. The removable backing can be made of paper, plastic,film, metal, elastomer, foam, fabric or combinations thereof. Thesubstantially parallel monofilaments may be positioned within theflexible adhesive such that they are touching each other along theirlength. The substantially parallel monofilaments may be positioned suchthat there is flexible adhesive separating each fiber along its length.

FIG. 46A illustrates fiber array layer 72 having a layer width 210 incross-section. The layer width 210 can include a number of fibers 86,for instance first fiber 86 a and second fiber 86 b. The layer 72 canhave a linear quantity fiber density measured, for example, as thenumber of fibers 86 per unit of layer width 210. The linear quantityfiber density can be equal to or greater than about 500 fibers per inch,more narrowly equal to or greater than about 1000 fibers per inch, morenarrowly equal to or greater than about 2000 fibers per inch, yet morenarrowly equal to or greater than about 4000 fibers per inch. Forexample, the liner quantity fiber density can be from about 1,000 fibersper inch to about 2,000 fibers per inch.

The fibers 86 or monofilaments can be high strength and inelastic. Thefibers can have a fiber or monofilament diameter 212, for example, fromabout 1 μm to about 50 μm, for example less than about 25 μm, morenarrowly less than about 15 μm. The unidirectional fiber-reinforced tapecan have the same or different sizes and materials of fibers within thesame unidirectional fiber-reinforced tape.

The fiber tape layer 72 can have a layer thickness 216 from about 1 μmto about 50 μm, more narrowly from about 8 μm to about 25 μm, yet morenarrowly from about μm to about 20 μm.

FIG. 46B illustrates that the fiber density can be less than the fiberdensity shown in FIG. 46A. For example, the fiber density can be about500 fibers per inch.

FIG. 46C illustrates that the inner layer 72 b can have a fiber tapehaving reinforcement fibers 86 in an adhesive 208. The outer layer 72 acan have a polymer film. The laminate shown can be a part of or theentire balloon wall 22,

FIG. 46D illustrates that the outer layer 72 a can be a fiber tape. Theinner layer 72 b can be a polymer film.

FIG. 46E illustrates that the outer layer 72 a and the inner layer 72 bcan be polymer films. In any variation, the polymer films can be thesame or different polymers, or any combination thereof. The first middlelayer 72 c can be a fiber tape.

FIG. 46F illustrates that the outer layer 72 a, inner layer 72 b, andsecond middle layer 72 d can be polymer films. The first middle layer 72c can be a fiber tape. Any adjacent layers, such as the third middlelayer 72 e and the outer layer 72 a can be joined with adhesive, bymelting, solvation, welding or combinations thereof.

FIG. 46G illustrates the outer layer 72 a, inner layer 72 b, firstmiddle layer 72 c and third middle layer 72 e can be polymer films. Thesecond middle layer 72 d can be a fiber tape.

FIG. 46H illustrates that the outer layer 72 a can be a first fibertape. The inner layer 72 b can be adjacent to the outer layer 72 a. Theinner layer 72 b can be a second fiber tape. The first and second fibertapes can be uni-tapes. The fiber in first fiber tape can form an anglewith the fiber in the second fiber tape. Part or all of the balloon wall22 can have multiple fiber tape layers in a wall section area 131. Thearea 131 can include a number of fibers.

Part or all of the balloon wall 22 can have a volumetric quantitativedensity of fibers measured, for example, as the number of fibers perunit of area. The area quantity fiber density can be equal to or greaterthan about 100,000 fibers per square inch, more narrowly equal to orgreater than about 250,000 fibers per square inch, more narrowly equalto or greater than about 1,000,000 fibers per square inch, yet morenarrowly equal to or greater than about 4,000,000 fibers per squareinch. The area quantity of fiber can be about 25% of the area of a wallcross section, more narrowly about 50%, more narrowly about 75%

The ratio of the volume of the fiber tape to the volume of the fibers 86can be about equal to or greater than about 15%, more narrowly equal toor greater than about 30%, more narrowly equal to or greater than about50%, yet more narrowly equal to or greater than about 75%.

FIG. 46I illustrates that a balloon wall 22 can be made by positioning,as shown by arrows, an inner layer 72 b having a first laminate 130 a onthe outer layer 72 a having a second laminate 130 b. The first laminate130 a can be consolidated to the second laminate 130 b. Consolidationcan include heating, pressurizing, solvating, or combinations thereof ofthe first laminate 130 a and the second laminate 130 b.

FIG. 46J illustrates that the outer layer 72 a, and inner layer 72 b canbe polymer films. The first middle layer 72 c and the second middlelayer 72 d can be fiber tapes.

FIG. 46K illustrates that the outer layer 72 a, inner layer 72 b, secondmiddle layer 72 d, and third middle layer 72 e can be polymer films. Thefirst middle layer 72 c and the fourth middle layer 72 f can be fibertape.

FIG. 46L illustrates that the balloon wall 22 can be made bypositioning, as shown by arrows, a first laminate 130 a on a secondlaminate 130 b. The first laminate 130 a can be consolidated to thesecond laminate 130 b. The first laminate 130 a can have the outer layerfixed to the fourth middle layer, which can be fixed to the third middlelayer. The second laminate 130 b can have the inner layer fixed to thefirst middle layer, which can be fixed to the second middle layer.

FIG. 46M illustrates that the outer layer 72 a, inner layer 72 b, secondmiddle layer 72 d, third middle layer 72 e, fifth middle layer 72 g, andsixth middle layer 72 h can be polymer films. The first middle layer 72c, fourth middle layer 72 f and seventh middle layer 72 i can be fibertapes.

FIG. 46N illustrates that the balloon wall 22 can be made by joining, asshown by arrows, a first laminate 130 a, a second laminate 130 b, and athird laminate 130 c.

FIG. 46O illustrates that the outer layer 72 a can be an MMA-resistantand MMA-releasing polymer film. The inner layer 72 b can be a leak proofbladder made from a polymer film. The first middle layer 72 c can be afiber tape, for example with the fibers oriented as longitudinal fibers.The second middle layer 72 d can be a resin or adhesive. The thirdmiddle layer 72 e can be a fiber tape, for example with the fibersoriented as latitudinal or hoop fibers. The fourth middle layer 72 f canbe a resin or adhesive. The fifth middle layer 72 g can be a radiopaquelayer, such as a metal foil. The sixth middle layer 72 h can be a resinor adhesive.

Any of the polymer or fiber tape layers can be leak proof, water tight,air tight, MMA-resistant, MMA-releasing, or combinations thereof.

Magnetic resonance visualization enhancement materials, such as magneticcontrast agents, can be added to the adhesive, the film or the fiber.The magnetic resonance visualization enhancement materials can enhancethe visualization of the balloon during an magnetic resonance imaging(MRI) procedure. For example, the magnetic resonance visualizationenhancement material can be gadolium, Omniscan, Optimark, ProHance,Magnevist, Multihance, or combinations thereof.

Any of the layers, for example the outer layer, can be tinted or dyed avisible spectrum color. For example, a pigment, coloring additive,dispersions or other coloring agents, such as an coloring additive fromPlasticolors (Ashtabula, Ohio) can be added to the adhesive, laminate orfiber before consolidation. A paint or coating can be added to a layersurface or to the outer surface of the balloon wall.

The color can be selected for branding, market differentiating, as anindication of the type of device, the size of the device, orcombinations thereof. For example, devices having a selected diameter,length, pressure rating, clinical indication or efficacy, other commonperformance metric, or combinations thereof, can be dyed a specificcolor (e.g., green for a first type of device, red for a second type ofdevice).

The layers can have one or more optical fibers. The fiber optic can be astrain sensor. The strain sensor can monitoring the laminate'smechanical status in real time. The fiber optic can guide light deliveryinto the body. The fiber optic can visualize a target site (e.g., gatherlight from the body to produce a visual image).

FIG. 47 illustrates polymer films from which the layers can be made. Thethickness of the polymer films can be from about 2 μm to about 50 μm,more narrowly from about 2 μm to about 18 μm, yet more narrowly fromabout 4 μm to about 12 μm.

FIG. 48 illustrates materials from which the reinforcement fibers can bemade.

FIG. 49 illustrates that the adhesive can be an elastomeric thermosetmaterial, an elastomeric thermoplastic material, or a combinationthereof. The adhesive can be selected from any of the materials, orcombinations thereof, listed in FIG. 49. The matrix can have a resin anda fiber. The resin can be an adhesive.

Method of Manufacture

FIGS. 50 and 51 illustrate that the device can be partially orcompletely manufacturing in a pressure chamber 219. The pressure chamber219 can be in a pressure chamber case 218. The pressure chamber case 218can have a case top 220 a separatable from a case bottom 220 b. The casetop 220 a can have a case top port 222. The case bottom 220 b can have acase bottom port 224. The case top port 222 can be in fluidcommunication with the top of the pressure chamber 219. The case bottomport 224 can be in fluid communication with the bottom of the pressurechamber 219.

The case top can screw or otherwise tightly join to the case bottom. Thepressure chamber case can have one or more O-rings (not shown) in o-ringseats 226.

The pressure chamber can have a mandrel seat 228. The mandrel seat 228can be configured to receive a mandrel 230. The mandrel seat 228 canhave holes or pores. The holes or pores in the mandrel seat 228 canallow pressure from the case bottom port and the bottom of the pressurechamber to reach the top surface of the mandrel seat around the mandreland/or directly under the mandrel.

The mandrel 230 can have the inner dimensions of the balloon 20.

The mandrel 230 can be a water soluble mandrel. The mandrel may be madefrom a low melting point wax or metal, a foam, some collapsing structureor an inflatable bladder. The mandrel can be made from a eutectic ornon-eutectic bismuth alloy and removed by raising the temperature to themelt point of the metal. The mandrel can be made from aluminum, glass,sugar, salt, corn syrup, hydroxypropylcellulose, ambergum, polyvinylalcohol (PVA, PVAL or PVOH), hydroxypropyl methyl celluslose,polyglycolic acid, a ceramic powder, wax, ballistic gelatin, polylacticacid, polycaprolactone or combinations thereof.

FIG. 52 illustrates characteristics of bismuth alloys from which themandrel can be made. The characteristics are characterized by meltingtemperature (as shown in the third row of FIG. 52) of the bismuth alloy.

The mandrel can be transparent or translucent to light and/or anelectron beam. The mandrel can be hollow. The outside surface of themandrel can be coated in a release agent.

The mandrel may be molded, machined, cast, injection molded orcombinations thereof.

The mandrel can be in the mandrel seat and a first panel to be formedinto about half of the inner layer of the balloon wall can be placedbetween the case top and the case bottom. The case top can then besecured to the case bottom.

FIG. 53 illustrates that the outer surface of the mandrel can have someglue or first adhesive. The first adhesive can be located around theperimeter of the first panel's contact area with the mandrel. The firstadhesive can be water soluble. The first adhesive can be a sugar syrup.

FIG. 54 illustrates that a positive pressure can be applied to the topof the pressure chamber (e.g., through the case top port) and/or anegative pressure or suction applied to the bottom of the pressurechamber (e.g., through the case bottom port). The layer can get suckedand/or pressed down onto the mandrel. The first panel can be smoothlyfitted to the mandrel and adhered to the mandrel at the first adhesive.

FIG. 55 illustrates that the mandrel and layer can be mounted into atrimming jig 231. Any excess portion of the first panel extending fromthe mandrel can be trimmed with a blade 235, with a laser, with a waterjet cutter or with a die cut tool. The trimming jig 231 can cover themandrel and the first panel attached to the mandrel. Several layers canbe formed over the mandrel and cut. The layers may be trimmed at thesame time or one at time.

FIG. 56 illustrates that the mandrel can have the excess area or thefirst panel removed in preparation for attachment to the second panel.

FIG. 57 illustrates that a second adhesive can be applied to the firstpanel around the perimeter of the second panel's contact area with thefirst panel. The second adhesive can be an epoxy, urethane, acyanoacrylate, a UV cure, or combinations thereof. The mandrel can beseated in the mandrel seat with the first panel in the mandrel seat. Thesecond panel can be placed on the mandrel as shown (upside down relativeto the FIGS. 50 and 51 for illustrative purposes).

FIG. 58 illustrates that after the case top is secured to the casebottom, the positive and/or negative pressures can be applied to thepressure chamber as described infra. The second panel can be smoothlyfitted or pressure formed to or against the mandrel and adhered to thefirst panel at the second adhesive. The first and second panels can formthe inner layer of the balloon wall. Multiple layers can be made byrepeating the method described infra. The pressure chamber can beheated, for example, to decrease the viscosity of and decrease themodulus of the panels.

FIG. 59A illustrates that a layer of fiber tape can be made on a roller232. The roller can be configured to rotate about a roller axle 234. Theroller may have a diameter from about 1 mm to about 100 mm. The rollermay be made or coated with an anti-stick material such as afluoropolymer.

FIG. 59B illustrates that a releaser 236, such as a release layer, canbe placed around the circumference of the roller 232. The release layercan be a low friction film or coating. The release layer may be athin/flexible flouropolymer sheet.

FIG. 59C shows that an adhesive layer can be placed on the releaser ordirectly onto the roller (e.g., if no releaser is used). The adhesivelayer may be a thermoplastic film. The adhesive layer may be a thermosetadhesive. The adhesive layer may be a solvated thermoplastic orthermoset.

FIG. 59D shows the application of fiber to the roller. Fiber may beunwound from a spool (not shown) and rolled onto the top surface of theadhesive. The fiber may contain one or more monofilaments. The fiber mayhave been previously flattened as detailed in this application. Anycoating or sizing on the fiber may have been removed using a solvent.The fiber may be placed with a gap between each successive fiber wrap.The gap may be less than 25 um, preferably less than 5 um.

FIG. 59E shows a reinforcement layer on top of the adhesive on top ofthe release layer.

FIG. 59F illustrates that the roller can be placed between a vacuum topsheet 238 a and a vacuum bottom sheet 238 b, for example in a vacuumbag. A vacuum seal tape 240 can surround the roller between the vacuumbottom and top sheets. The air can be removed from between the vacuumtop and bottom sheets and within the vacuum seal tape, for example bysuction from a suction tube 242. Inside and/or outside of the vacuumbag, the roller can be heated, for example to melt or cure the adhesive.

FIG. 59G shows the removal of the layer. For instance, a cut may be madesubstantially perpendicular to the fiber. The layer may be peeled awayfrom the release layer.

FIG. 59H illustrates that the layer of fiber tape can be removed fromthe roller. For example, the layer can be peeled off the releaser.

The layer can be cut into a pattern. For instance, the layer can be cutwith the trimming jig, a laser, a water jet cutter, a die cut tool, or acombination thereof. The layer can be cut to form a strip similar to theone shown in FIG. 121.

FIG. 60 illustrates that a strip can be applied to the inner layer orthe mandrel. Each strip can be placed around the distal terminal end ofthe mandrel. The circular section may be centered on the distal end ofthe mandrel. The strips may be adhered to the mandrel using an adhesiveor by melting the adhesive such that it bonds to the underlying layer.

FIG. 61 illustrates that a first, second and third strip can be laidonto the mandrel. For example, the strips can be placed on the inner (oranother) layer 72. The strips can cover the outermost (at the time thestrips are applied) layer. The ends of the strips can end on theproximal taper or proximal stem.

FIG. 62 illustrates that the circular sections of each strip can line upwith each other. The circular sections can be aligned with the balloondistal terminal end. There may be fibers located approximately every 60degrees at the distal tip

FIG. 63 illustrates that fiber can be wound over the mandrel. Forexample, a tool arm 246 can be attached to a rotating tool wheel 248.The mandrel can be rotated, as shown by arrow 252, about the mandrellongitudinal axis 250 or balloon longitudinal axis. The spool 244 can bepassively (e.g., freely) or actively rotated, as shown by arrow 254,deploying the fiber. Before winding, the fiber may be infused with anadhesive, a solvent, or both. A fiber distal end can fix to the toplayer or directly to the mandrel. The tool arm 246 can rotate andtranslate, as shown by arrows 256 and 258, to track the tool wheel withthe surface of the top layer.

The tool wheel can press the fiber against the top layer. The tool wheelcan be heated to soften or melt the material on the surface of the toplayer. Another heat source may be used to tack the fiber in place. Forexample, a separate resistive heater, a laser, or an RF welder may beused. The tool wheel can be made of or coated with a non-stick material.The fiber may be wound with a gap between each successive fiber wind.The gap can be less than about 25 μm, more narrowly less than about 5μm. The winding process can terminate substantially before reaching thedistal tip. The winding process can terminate when the fiber reaches thearea where the strips overlap.

The resulting layer deposited in FIG. 63 can have a layer thickness offrom about 1 μm to about 50 μm, more preferably, 8 μm to about 25 μm.

FIG. 64 illustrates that a string, wire or fiber can be helicallywrapped around the mandrel, for example on the inner (or another) layer.

FIG. 65 illustrates that a rosette, vanes, or spots of a single panelcan be placed onto the mandrel. The panel can be made from a metal foil.The rosette may be that shown in FIG. 44. The panel may provideradiopacity to the balloon. The panel may strengthen the balloon. Thepanel may make the balloon significantly more resistant to puncture.

Any methods of adding a layer to the mandrel or previous layer can berepeated to add additional layers, such as an outer layer of anMMA-resistant film.

The mandrel and the layers, including the panels, strips, wires orfibers, rosette, or combinations thereof, can be adhered, heated and/orpressurized, for example, to melt solvate, or otherwise bond the layers,for example by creating molecular bonds and decreasing the viscosity andmodulus of the layers.

FIG. 66 illustrates that after the layers of the balloon have beenassembled on the mandrel, a distal caul 260 a can be placed over thedistal end of the balloon. A proximal caul 260 b can be slid over themandrel and the proximal end of the balloon. The proximal caul 260 b canbe sealed to the distal caul 260 a. The cauls 260 can be made from aflouropolymer. The cauls 260 can have thermoformed FEP with a 0.005 in.initial thickness.

FIG. 67 illustrates that the mandrel, balloon and cauls can be placedinto a vacuum bag. The balloon proximal stem and/or the mandrel can beplaced inside of a vacuum bag. The interior of the vacuum bag can beheated. The vacuum bag can be inserted inside of an oven or autoclave.The layers of the balloon on the mandrel can be thermally cured ormelted, for example under from about 1 ATM to about 30 ATM of pressure.

The bag delivery channel can suction the interior of the vacuum bag. Forexample the pressure in the vacuum bag can be less than about 0.1 ATM.

FIG. 68 illustrates that a wash tube 264 can be inserted into a mandrelwashout port 262. A dissolving or solvating fluid can be deliveredthrough the wash tube and into the washout port. The mandrel can beremoved by delivery of a fluid solvent such as water, alcohol or aketone. The solvent may be applied during the consolidation process suchthat the solvent melts or partially softens the mandrel and concurrentlypressurizes the bladder. The mandrel can be removed by raising themandrel to a melting temperature for the mandrel. The mandrel can beremoved by deflating the mandrel or by collapsing an internal structure.

The balloon may be expanded under pressure inside of a female mandrel.The mandrel inside diameter may be sized so that a pressurized balloonjust contacts the inner wall of the mandrel. Heat may be applied. Heatmay cause the wall of the balloon to soften and form against the insideof the female mandrel. This may give the balloon a smoother outer layerand serve to tension the fibers in the balloon.

FIG. 69 illustrates that a pleated balloon in an expanded or inflatedconfiguration can be substantially circular in cross-section.

FIG. 70 illustrates that a balloon can be clamped in a pleating tool 266with two, three, four, five or more removable pleating blocks 268.Heating the pleating blocks 268 to about 80 Celsius and then pressingthem against the balloon for about 1 minute causes the balloon to becomepleated or fluted. Commercial pleating machines such as balloon foldingmachinery from Interface Associates (Laguna Niguel, Calif.) can also beused. A small amount of wax may be used to hold the pleated and foldedballoon into its desired shape.

FIG. 71 illustrates that a pleated balloon in a deflated or contractedconfiguration can have one or more pleats.

Uni-tape layers can be their own layers.

FIG. 72 and FIG. 73 illustrate one method of uni-tape fabrication. Towsor bands 270 provide the extruded monofilaments or fibers 86 which areoptionally passed through a treatment bath 272 to improve adhesivebonding features of the exterior of the monofilaments via chemicaletching, plasma arc etching or corona discharge etching. The pretreatedmonofilaments from the tows are pulled through an adhesive bath 274 overand under first rollers 232 a where the matrix adhesive coats andsurrounds the monofilaments.

The adhesive-coated monofilaments are drawn through a fixed gap rotarydie 278. Release material 276 from second rollers 232 b can be appliedto the top and bottom of the adhesive coated monofilaments, for example,prior to the pulling of the tows 270 through the fixed gap rotary die278 which controls adhesive content and spreads the filaments. During apull-trusion process, the individual tows are laterally joined to form auni-tape which is heated by a heater 280 for viscosity change, afterwhich the tape is compacted via rolls third rollers 232 c. The compactedtape can then be passed over a chill plate 282 to the spool 244, withthe top sheet of release material being removed at roll fourth roller232 d and reeled up on fifth roller 232 e.

The monofilaments can be subject to less than about 0.02 pounds oftension during assembly substantially immediately before themonofilaments set in the adhesive matrix. For example, substantially notensioning can be applied to the monofilaments during manufacturingimmediately before the monofilaments set in the adhesive matrix.

Another kind of fiber tape (hereafter referred to as woven tape) mayhave a woven, knitted or braided fiber cloth, a flexible adhesive, andan optional removable backing or combinations thereof. The removablebacking can be made of paper, plastic, film, metal, elastomer, foam,fabric or combinations thereof.

Woven, knitted and braided cloths are known though modern textileproducts. Typically, weave patterns feature a warp threads, running in afirst direction, and weft threads, running in a second direction. Theangle between the first and second directions may be 90 degrees. Theangle between the first and second directions may be 75 degrees. Theangle between the first and second directions may be 60 degrees. Theangle between the first and second directions may be 45 degrees. Theangle between the first and second directions may be oriented at anyappropriate angle. In the process of weaving, the threads may beinterlaced in various ways to form weave patterns depending on theproperties desired.

Another kind of fiber tape (hereafter referred to as matted tape) canhave matted fiber, a flexible adhesive, and an optional removablebacking or combinations thereof. The removable backing can be made ofpaper, plastic, film, metal, elastomer, foam, fabric or combinationsthereof. The matted fiber may be a collection of randomly orientedfibers of different lengths.

FIG. 74 shows that layers 72 c and 72 d can have reinforcement fibers 86oriented in the same direction. This is a 0-0 arrangement, because ofthe angle that each layer 72 d makes with a vector aligned with thefibers of the bottom layer 72 c. This arrangement may provide twice thestrength in the fiber direction as the uni-directional tape itself.

FIG. 75 shows that layers 72 c and 72 d can have reinforcement fibers 86oriented perpendicular to each other. This is a 0-90 arrangement,because of the angle that the second layer 72 d makes with a vectoraligned with the fibers of the bottom layer 72 c. This arrangement mayprovide substantially the same strength in the 0 degree and 90 degreedirection as the uni-directional tape itself.

FIG. 76 shows that layers 72 c, 72 d and 72 e can have reinforcementfibers 86 oriented at 0-0-90 to each other. This arrangement may provideapproximately twice the strength in the 0 direction than a single layerof uni-tape provides. This arrangement may provide strength in the 90direction approximately equal to that of a single uni-tape.

FIG. 77 shows that layers 72 c, 72 d, 72 e, 72 f, 72 g, and 72 h can beoriented at 0, 30, 60, 90, −30, −60 respectively to each other.

A laminate may include one or more fiber tapes. A laminate may includeone or more polymer films.

The one or more fiber tapes and, optionally, the one or more polymerfilms can be consolidated into a laminate. Consolidation may includecompaction and curing or melting. Compaction can occur before curing ormelting. Compaction may include the application of heat and/or lightand/or an electron beam, the application of force (i.e., pressure), andthe passage of time. Curing or melting may include the application ofheat or light, the application of force (i.e., pressure), and thepassage of time.

During the process of consolidation, fibers may shift position withinthe laminate. During the process of consolidation, the fibers may getcloser to each other within the laminate.

The polymer film or polymer films may melt during the consolidationprocess or the polymer films may not melt. The polymer films can be onone or both outer surfaces of the laminate and different materials canbe put on each side. The polymer film can be on only one side of thelaminate, or absent altogether.

The polymer film could be formed by applying a polymer in a wetapplication process, such as spraying, dipping, painting, orcombinations thereof.

The polymer film may be coated with a material. The coating may beapplied by, for instance, sputter coating. The material that is coatedon the polymer film may provide substantial radiopacity.

FIG. 78 shows an example of the fabrication of a laminate by using anauto clave. Various layers of fiber tape material 72 c, 72 d, and 72 ecan be between an outer layer 72 a of a film and an inner layer 72 b ofa film. The fiber tape material and the films can be between a topvacuum sheet 238 a and a bottom vacuum sheet. The bottom vacuum sheetcan be placed on a rigid plate or platen 288. Sealing is provided byseals 286. A breather material 284 may be between the outer layer 72 aand the top vacuum sheet 238 a, for example for evacuating gas frombetween the vacuum sheets. The enclosed volume or bag between the topand bottom vacuum sheets can be evacuated at the suction tube 242.

During the autoclave process as illustrated in FIG. 79, the processsteps are first to lay down the bottom vacuum sheet as illustrated at290. Secondly, one optionally lays down the inner layer 292 to belaminated or consolidated as illustrated at 292, followed by the peelingoff of the removable backing and laying down the first middle layer asillustrated at 294. Thereafter as illustrated at 296, optionaladditional middle layers can be laid down after removal of theirremovable backing. Additional fiber tape can be laid down in additionaldirections as needed. Thereafter, the outer layer can be optionally laiddown as illustrated at 298. A breather material 284 may be positionedbetween the outer layer and the and top vacuum sheet. The top vacuumsheet can be laid down over the breather material 284 as illustrated at300. The structure can be placed in an autoclave as illustrated at 302.The volume between the bottom and top vacuum sheets can be evacuatedafter sealing the edges as illustrated at 304.

Thereafter, as part of a consolidation phase, follows a compaction phaseas illustrated at 306 at the requisite pressures and temperatures.Thereafter, as part of a consolidation phase, follows a curing or meltphase as illustrated at 308 at associated pressures and temperatures.

One set of pressures and temperatures useful for a compaction or cure ormelt phase is illustrated in FIG. 80 by the temperature time graph andassociated temperature pressure graph.

Several laminates, each with different fiber orientations and adifferent number of layers, may be created. Alternately, a singlelaminate may be constructed with multiple fiber orientations and layerquantities placed into different regions of the larger laminate. Fromthis single laminate, smaller laminates with specific fiber orientationscan then be removed and used to create a medical inflatable.

The choice of a film for the inner or outer surface can providedesirable properties.

If it is desired that the outside of the laminate be low friction andresistant to harm from chemicals, or that the laminate readily releasefrom certain adhesives (such as, for instance, Methyl methacrylate, aprincipal ingredient in bone cement), a fluoropolymer such as FEP(Fluorinated ethylene propylene) may be selected for the outer layer.One side or both sides of the FEP film may be treated via a plasmamethod a corona discharge method or via an etchant or by somecombination thereof. These treatments may make the flouropolymer filmeasily bondable on one or both of its surfaces. The film may also bepurchased in a bondable state. A treated surface can form a strong bondwith an adhesive, such as the adhesive in the fiber matrix. A surfacemade bondable may be restored to an unbondable state.

A metal film or foil layer on the outside of the balloon can also beused to resist chemical attack. This metal film or foil layer may givethe balloon radiopacity. The outer surface of the balloon may also havea coating that may help the balloon resist chemical attack. The coatingmay be flouropolymer based.

The laminate can be made as describe in U.S. Pat. No. 5,333,568 or5,470,632, both of which are herein incorporated by reference in theirentireties.

A layer may be leak tight. The layer may be made by dip molding, forexample, urethane or nylon, over a mandrel. The layer may be made byrotational molding.

The layer may be made by coating a substance over the mandrel or theballoon. A coating may be, for instance, parylene. A coating may be ametal, such as gold. A coating may electrodeposited, electrolessdeposited or via physical vapor deposition or a combination thereof. Acoating may have significant radiopacity. A coating may increase thetoughness of the balloon, or increase its lubricity. A coating mayreduce or eliminate attack or adhesion from chemicals. For instance, acoating may cause the balloon to not be attacked or to adhere to bonecement.

A layer may be formed by conformal coating. A conformal coating mayinclude a flouropolymer. The coating may be dipped on, sprayed on orapplied by electrostatically charging the substrate or by combinationsthereof. Coatings may be cured by baking.

A layer may be formed by blow molding. The blow molding process caninclude a parison. The parision may be open at both ends, or only openat one end (a “blind” parison).

FIG. 81A illustrates that the mandrel can have a spiral groove. Thefiber can be wound in the spiral groove. The spiral groove can be on theproximal stem, proximal taper, constant diameter section, distal taper,any steps, or combinations thereof.

FIG. 81B illustrates that the mandrel groove 310 can be stepped alongthe length of the mandrel. The fiber can be wound one or more (as shown)times on each step of the groove 310.

FIG. 81C illustrates that the mandrel groove 310 can be bound by grooveedges 312 that can be raised above the level of (i.e., have a largerradius than) the mandrel groove. The groove edge 312 can interferencefit against the fiber. The groove edge height can be equal to or greaterthan the diameter of the fiber.

FIG. 81D illustrates that the mandrel groove can be configured toreceive a second fiber having a second fiber diameter. The second fibercan be wound into the second mandrel groove. A first fiber having afirst fiber diameter can be wound between the windings of the mandrelgroove. The second fiber can act as a groove edge to the first fiber,interference fitting the first fiber to trap the first fiber betweenwindings of the second fiber. The fibers can have a diameter of fromabout 0.0005 in. to about 0.004 in. For example the first fiber can havea first fiber diameter of about 0.00075 in. and the second fiber canhave a second fiber diameter of about 0.004 in.

FIG. 82A illustrates that a fiber tool 314 can be used to configure thefiber into a spiral configuration. The fiber tool 314 can have a fibertool first part 316 a removably attached to a fiber tool second part 316b. The fiber tool second part can have a tool axle 322. The fiber toolfirst part can have a tool hub 320. The tool axle 322 can be rotatablyand/or removably received by the tool hub 320.

The fiber tool 314 can form a fiber gap 318 between the fiber tool firstpart 316 a and the fiber tool second part 316 b. The fiber gap 318 canhave a fiber gap width 324. The fiber gap 318 can be adjusted by, forexample, the use of a feeler gauge. The gap width can be from about 15μm to about 200 μm, more narrowly from about 15 μm to about 100 μm, morenarrowly from about 15 μm to about 35 μm. The fiber gap width 324 can beabout, or nominally larger than, the diameter of the fiber.

FIG. 82B illustrates that the fiber can be wound into the fiber gap 318.The fiber gap can be straight, for example having a circularconfiguration. A first release layer and a second release layer may beplaced on the inside walls of the fiber gap. An adhesive may be placedin contact with the fiber. The adhesive may be a thermoplastic or athermoset. The adhesive may be cured or melted. The adhesive may be inplace before, during or after the fiber is added to the fiber tool. Theadhesive can be a resin. A port (not shown) can be added to the toolsuch that, under pressure, resin and/or solvent can be infused into thefiber in the gap. The resin and/or solvent can extrude out the perimeterof the gap. The gap can be sealed created a closed volume. The resinand/or solvent can be delivered under pressure into the closed volume ofthe gap to infuse the fiber.

FIG. 83 illustrates that after the adhesive is cured or melted, thefiber tool first part can be removed from the fiber tool second part.The wound fiber and adhesive, as shown, can then be removed from thefiber tool. The wound fiber can have a substantially flat or conicalconfiguration.

FIG. 84 illustrates that the fiber gap can be v-shaped in cross-section,for example having a conical configuration.

FIG. 85 illustrates the fiber and adhesive panel after coming out thetool pictured in FIG. 84.

FIG. 86 illustrates that the wound fiber can be pressure-formed on amandrel.

FIG. 87 illustrates that the shape of the fiber can be distorted by themandrel to have a wall having a concave, convex or s-curve.

Pressure forming may allow the conical panel to be formed into a shapethat more readily matches the shape of a portion of the balloon. Theresulting conical panel may be placed onto the balloon and cured ormelted into place.

FIG. 88 illustrates an alternate method of applying a fiber tape to aballoon 20. The balloon 20 can have continuous laminates that start at afirst end of a mandrel, 230 go to the opposite end of the mandrel 230and return to the first end of a mandrel 230. The laminate may startsubstantially at the first end of the mandrel 230 or near the first end,for example within 4 mm. The balloon 20, the bladder or inner layer, ora mold can be substituted for the mandrel 230 in this variation.

FIG. 89 illustrates that the mandrel can have one or more cross channels328 through the mandrel. The cross channels 328 can have cross channelports 330 on the surface of the mandrel. One or more internal restraintscan be placed through the mandrel. The restraints may comprise a fiber.A continuous restraint may pass thru one, some or all of the holes inthe mandrel

FIG. 90 illustrates that the mandrel can have a cross channels that canbe parallel with one or more (shown as three) adjacent cross channels.The cross-channels can be curved.

FIG. 91A illustrates that the cross-channel can transect the diametriccenter of the mandrel. The cross-channel can be straight.

FIG. 91B illustrates that the balloon can have an inner layer and anouter layer. The internal restraint can be fixed to the radial outsideof the outer layer.

FIG. 91C illustrates that the internal restraint can be fixed betweenthe inner layer and the outer layer.

FIG. 91D illustrates that the internal restraint can be fixed to theradial inside of the inner layer.

FIG. 92 illustrates a portion of an alternate process for applying fibertape to a mandrel. FIG. 92 illustrates that the first, second, third andfourth strips 192 a, 192 b, 192 c, and 192 d may have one or more layersof uni-tape oriented along the long axis of the laminate (this fiberorientation is shown in the figure). The strips 192 can be rectangular.The strips 192 can have adhesive. Each strip may be oriented parallel tothe mandrel longitudinal axis or balloon longitudinal axis. Enoughstrips can be used such that the strips encircle the mandrel's largestdiameter. The strips may overlap each other. The mandrel can have one ormore layers on the mandrel before the strips are applied.

FIG. 93 illustrates that a panel may be applied to a mandrel with none,one or more layers on the mandrel. The panel can have one or more layersof uni-tape oriented along the long edge panel longitudinal edge 332.The panel can have a panel width 334. The panel can have a panelrectangular section 336 and one or more panel serrations 338. The anglebetween the serrations 338 can be a panel serration angle 340. The panelserration angle 340 can be about 30°, about 20°, about 10°, or about 0°.The panel longitudinal edge can be oriented parallel to the mandrellongitudinal axis or the balloon longitudinal axis. Parts of the panelmay overlap other parts of the panel.

FIG. 94 illustrates that the panel can be applied to a mandrel withnone, one or more layers on the mandrel. The panel can have one or morelayers of uni-tape oriented perpendicular to the panel longitudinal edge332. The panel can have multiple layers of uni-tape oriented atdifferent angles in the panel (not shown). The uni-tape may make angles(not shown) of about 30°, about 45°, or about 60° with panellongitudinal edge 332.

The panel width can be more than about three times the circumference ofthe balloon, layer or mandrel. The panel can be wrapped around theballoon, layer or mandrel about three times. The panel width can be morethan about five times the circumference of the balloon, layer ormandrel. The width can be more than about ten times the circumference ofthe balloon, layer or mandrel.

FIG. 95 illustrates that a first panel 196 a can have eight serrationsand a panel latitudinal edge 333. The first panel 196 a can be alaminate of resin and fiber, as described herein. A first line 346 a canbe marked on the surface of the first panel 196 a and may be parallel tothe latitudinal edge 333 and located about 3 mm from the latitudinaledge 333. The first panel 196 a can have a panel bottom edge 344 and thepanel longitudinal edge 332. The panel bottom edge 344 can have a lengthof about 58 mm (2.3 in.). The panel longitudinal edge 332 can have alength of about 50 mm in length. The distance from the serration tip 342to the first line 346 a can be about 16 mm. The distance from the panelbottom edge 344 to the first line 346 a can be about 47 mm. The secondline 346 b can be marked on the surface of the panel. The second line346 b can be perpendicular to first line 346 a. The second line 346 bcan intersect a serration tip 342. The second area 348 b of the panelbelow the first line 346 a can have four unidirectional reinforcementfiber tapes laid sequentially in the 0 degree direction. The second area348 b can have two uni-tapes laid sequentially in the 90 degreedirection. The first area 348 a of the panel above the first line 346 acan have two uni-tapes oriented sequentially in the 0 degree directionand two uni-tapes oriented sequentially in the 90 degree direction.

FIG. 96 illustrates that a second panel 196 b can be circular. Thesecond panel 196 b can be about 28 mm in diameter and can have aboutfour slits or cuts 350. Each cut 350 can be about 7 mm long. Four tabs352 can be formed by the cuts 350. The second panel can have one each ofthe uni-tapes oriented sequentially at each of 0°, 30°, 60°, 90°, −30°,and −60° angles.

FIG. 97 illustrates that a third panel 196 c can be shaped like aparallelogram with first side edge 356 a parallel to second side edge356 b and third side edge 356 c parallel to fourth side edge 356 d. Thefirst side edge 356 a can form an acute angle with third side edge 356 cof about 70°. The first side edge 356 a can be about 13 mm long. Thethird panel 196 c can have one uni-tape oriented in about the 0°direction and one uni-tape oriented in about the 90° direction.

FIG. 98 illustrates that a fourth panel 196 d can be rectangular. Thefourth panel 196 d can have first and second long edges 358 a and 358 cand first and second short edges 358 b and 358 d. The long edges 358 aand 358 c can be about 58 mm. The short edges 358 b and 358 d can beabout 3 mm long. The fourth panel can have about three uni-tapesoriented sequentially in about the 0° direction and about one uni-tapeoriented about in the 90° direction.

FIG. 99 illustrates that the fifth panel 196 e can have panel serrations338 and a panel latitudinal edge 333. The first line 346 a can be markedon the surface of the fifth panel 196 e and may be parallel to thelatitudinal edge 333 and located about 8 mm from latitudinal edge 333.The fifth panel can have a bottom edge 344 about 57 mm in length. Thedistance from the tip of the serrations to the dotted line can be about7 mm. The distance from the bottom edge to the dotted line can be about43 mm. The second area 348 b of the panel below the first line 346 a mayhave four uni-tapes oriented sequentially in the 0° direction and twouni-tapes oriented sequentially in the 90° direction. The first area 348a of the panel above the first line can have two uni-tapes orientedsequentially in the 0° direction and two uni-tapes oriented sequentiallyin the 90° direction.

FIG. 100 illustrates that the sixth panel 196 f can have a circular edge360 with a radius of curvature of about 20 mm. The sixth panel 196 f canhave panel first and second radial edges 362 a and 362 b that connect tothe panel circular edge 360 and connect to the center of the radius ofcurvature of the panel circular edge 360. The sixth panel can have oneeach of the uni-tapes oriented sequentially at each of 0°, 30°, 60°,90°, −30°, and −60° with respect to each other.

FIG. 101 illustrates that the mandrel 230 can have a mandrel constantdiameter section 370 of about 17.07 mm in diameter and about 76 mm inlength. The mandrel 230 can have a mandrel transition 366 where thefirst constant diameter section meets the distal taper approaching themandrel terminal distal end 372. The mandrel 230 can have a mandrel stem364 and mandrel proximal taper 368. The mandrel 230 can have mandreltransition 366 where the proximal taper 368 meets the mandrel constantdiameter section 370. The mandrel 230 can have a mandrel transition 366where the radius stem 416 meets transition radius. The mandrel can havetransitions 366 between lengths.

FIG. 102 illustrates that the first panel 196 a can be wrapped aroundthe distal end of the mandrel 230. The first line 346 a can be alignedwith mandrel transition 366 at the distal end of the mandrel 366.Adhesive can be placed in the region of overlap seam 66 to secure thepanel on the mandrel. The adhesive can hold the panel closed around themandrel. Standard cellophane tape 374 (also element 343) can secure thepanel to the mandrel. Adhesive may next be applied to completely coverthe outer surface of the serrations. Every other serration can be firstfolded over the mandrel distal taper. The remaining serrations can thenbe folded onto the mandrel distal taper.

FIG. 103 illustrates the mandrel 230 with the first panel 196 a appliedto the mandrel 230 as described infra and in FIG. 73.

FIG. 104 illustrates that the second panel 196 b can be centered on topof the distal taper. Any cut 350 in the panel can be aligned with thesecond line 346 b on the first panel 356 a. The four tabs 352 of thesecond panel can be folded over the serrations 338.

FIG. 105 illustrates the mandrel with the first and second panels 196 aand 356 b applied to the mandrel as described herein.

FIG. 106 illustrates that the fourth panel 196 d can have adhesiveapplied to one surface. Second long edge 358 c of the fourth panel 196 dcan be aligned with the first line 346 a on the first panel 196 a. Thefirst long edge 358 a can be positioned proximal to the first line 346a. The fourth panel 196 d can be wrapped around the mandrel, with theadhesive on the fourth panel facing toward the mandrel. The balloonsecond section 384 b can be removed from the mandrel.

FIG. 107 illustrates that the balloon second section 384 b. The distalballoon fragment can have balloon outer diameter 50.

FIG. 108A illustrates that the female mold 376 can be made of a firstmold half 378 a and a second mold half 378 b. When the two mold halves378 a and 378 b are brought together, they can form a center mold lumen380 where the second balloon section 384 b may be placed in the mold376. A mold port 382 in mold second half 378 b is in fluid communicationwith the mold lumen 380. The mold port 382 can be used to connect avacuum pump when curing a balloon fragment. The balloon fragment 384 canbe placed in the mold lumen 380.

FIG. 108B illustrates that an optional first releaser 236 a can beapplied to the inside of the female mold 376. The first releaser 236 acan be a grease, a non-stick film or a non-stick tape or sheet. A secondreleaser 236 b can be placed on top of the balloon fragment 384. Thissecond mold releaser or release agent can be a grease or a non-stickfilm. A breather material 284 can next be placed for purposes ofequalizing the pressure during a curing cycle. A vacuum bag or topvacuum sheet and a seal can be installed. The mold port can forms afluid connection from outside the mold to the space between the vacuumbag or top vacuum sheet and the inner wall of the female mold. Thisfluid connection can remain unobstructed by the first mold releaser orrelease agent, balloon fragment 384, second mold release agent, andbreather material 284, when a vacuum pressure is applied to the moldport. The distal balloon fragment 384 may be consolidated.

FIG. 109 illustrates that the third panel 196 c can be coated on oneside with adhesive. The third panel 196 c may be wrapped around themandrel stem with the adhesive side facing away from the mandrel stem.The third panel 196 c can be wrapped such that the fourth side edge 356d is approximately coincident with the mandrel transition from themandrel stem to the mandrel proximal taper.

FIG. 110 illustrates that the fifth panel 196 e can be wrapped aroundthe proximal end of the mandrel. The serrations can point in theproximal direction. The first line 346 a may be aligned about 7 mmproximal to the transition between the mandrel proximal taper and themandrel constant diameter section. The first line 346 a can be alignedparallel to the mandrel transition. Adhesive can be applied on the panelwhere the panel overlaps with itself. Adhesive can be applied tocompletely cover the surface of the serrations that face out from themandrel. Every other serration may first folded over the proximal taper.Then the remaining serrations may be folded onto the cone.

FIG. 111 illustrates that the sixth panel 196 f may be wrapped over theproximal taper the sixth panel, when wrapped around the proximal tapercan cover more than about 2 mm of the mandrel stem and more than about 2mm of the mandrel constant diameter section.

FIG. 112 illustrates that the balloon first and second sections 384 aand 384 b can be slid together such that they overlap by about 6 mm. Anadhesive can be placed in the overlap region or seam. The first andsecond balloons sections and adhesive may be placed in a female mold. Acompliant balloon or bladder may be inserted inside the balloonfragments. The balloon may be consolidated to form a fiber reinforcedballoon, 10 and 20, capable of sustaining pressure.

FIG. 113 illustrates that a second balloon fragment 284 b that can havethe third, fifth and sixth panels 196 c, 196 e, and 196 f combined. Theproximal balloon fragment may be placed under vacuum in a female moldand consolidated.

The longitudinal length 388 of the constant diameter section of secondballoon section 384 b can be trimmed to about 9 mm long.

FIG. 114 illustrates that a solid release film (not shown) such asTeflon may be inserted into the interior of the balloon. The first andsecond balloon sections 384 a and 384 b can be clamped together byclamps 386. The balloon sections 384 can be consolidated to form a fiberreinforced balloon 20 capable of sustaining pressure.

Additional laminates can be added to areas of a balloon that mightrequire extra strength for certain procedures or uses. A balloon mayhave different amounts of fiber, adhesive or polymer film in differentportions of the balloon wall. A balloon may have different number offiber layers in different portions of the balloon wall.

FIG. 115 illustrates a variation of the assembled device.

FIG. 116 illustrates that a first panel of polymer can rest on top ofthe female mold half. (The first panel can be a see-through polymer forillustrative purposes, for example the contours of the mold may beseen.) The first panel can be a polymer, such as a nylon, PET,polycarbonate, urethane or any other polymer that can be readily formed.The first panel be about 0.002 inches thick, more narrowly about 0.001inches thick, yet more narrowly about 0.0005 inches thick.

FIG. 117 illustrates that the first panel can be formed to the contoursof mold.

FIG. 118 illustrates that the first panel can be lifted free of themold. The first panel can have a panel flat 390 that did not enter theform of the female mold during forming. The panel can be trimmed, forexample in a trimming jig.

FIG. 119 illustrates that first and second panels can have their flats390 trimmed. The two panels can be closed tightly around a mandrel and amandrel shaft 392. The panels can then be bonded to each other at thepoint where they overlap. The bond may connect all or some of thematerial that overlaps. The bond may be leak tight to the passage or airand water. Bonding may take place by addition of an adhesive, by theapplication of heat, by the application of ultrasonic energy, by use ofa laser, by the application of radio frequency energy, by theapplication of pressure or by combinations thereof. A material may beadded to the joint that enhances the effectiveness of these bondingtechniques.

FIG. 120 illustrates that inner layer may be constricted over a mandrelwhich is not removable. The inner layer can be constructed inside afemale mold (not shown) that matches the intended outer shape of theinner layer. Both a mandrel and a female mold may be used together tocreate a narrow thickness for the inner layer to be formed in. The innerlayer may be thermoformed, or injection molded or constructed via someother method listed supra. The inner layer can be slit 394, removed fromthe non-removable mandrel and placed over a removable mandrel (asdescribed above). The slit 394 can then be patched with a thin strip ofpolymer attached to inner layer.

An inner layer may be formed by a standard blow molding process such asextrusion blow molding, injection blow molding, or stretch blow molding.The inner layer may be checked for leaks before being used.

FIG. 121 illustrates that a strip 192 can be an elongated element ofpolymer film, metal foil or fiber tape cut into a shape that may beuseful in creating a fiber reinforced balloon. The shape of the strip192 may be cut by hand, with a high pressure water jet or with a laser.Extending longitudinally from a first end of the strip 192 to a secondend of the strip 192, the strip 192 can have a first narrow section 396a, a first taper, a first wide section 398 a, a first central narrowing,a circular section 402, a second central narrowing, a second widesection 398 b, a second taper, and a second narrow section 396 b. Thestrip can have one or more reinforcement fibers. The reinforcementfibers can be substantially aligned with the strip longitudinal axis.For example, the strip 192 can have uni-tape. The strip 192 can have oneor more layers. The reinforcement fibers can extend the entire length ofthe strip 192. A polymer film (not shown) can on one side or both sidesof the strip 192. The strip 192 can be flexible before and afterconsolidation.

FIG. 122 illustrates that fibers in strip 192 can be unidirectional andcan be substantially aligned with the strip longitudinal axis. The stripcan be substantially rectangular. A polymer film (not shown) can beplaced on one side or both sides of the strip 192. The strip 192 can beflexible before and after consolidation.

FIG. 123 illustrates that a first, second and third strip 192 a, 192 b,and 192 c can be aligned at equal strip angles 404 to each other to forma rosette. The strip angle 404 can be the angle from the first striplongitudinal axis to the adjacent strip longitudinal axis. The circularsection 402 for each strip 192 can be substantially concentric to thecircular sections for the other strips 192.

FIG. 124 illustrates that the strips 192 can have no reinforcementfibers.

FIG. 125 illustrates that strip can be applied to the inner layer (e.g.,bladder). The inner layer can have a hard mandrel inside of the innerlayer. The mandrel can support the surface of the inner layer. Thecircular section 402 of the strip can be concentrically aligned with theterminal distal end of the inner layer and adhered in place. Theremainder of strip can be laid over the contours of inner layer orbladder such that narrow sections of fiber tape partially cover stem onbladder.

Several pieces of fiber tape may be applied to bladder. Each piece maybe concentrically aligned with the tip of the distal end of the bladderand adhered in place. However, alignment may be such that the fiber tapecover sections of bladder and shaft that have not yet been covered withfiber tape or have not yet been covered with fiber tape with fibers insubstantially similar orientations. Two to eight pieces of fiber tapemay be applied in this manner. Application may continue until all ofbladder 72 b is covered in fiber tape with fibers substantially orientedalong the long axis of the mandrel and stem.

FIG. 126 illustrates that fiber tape may be applied to a flexiblebladder or inner layer. The bladder can be supported by the presence ofmandrel inside of it. Fiber tape may be wrapped from two to eight timesaround the largest diameter of the bladder. FIG. 210 shows fiber tapewrapping more than three and less than four times around bladder. At theend of this wrapping procedure, fiber tape may be tightly wrapped aroundthe largest diameter of mandrel.

FIG. 127 illustrates that fiber may be wound around flexible bladder orinner layer. Bladder may be supported by the presence of mandrel insideof it. Fiber 86 may be uni-directional fibers with or without adhesive.Fiber may be a continuous piece of fiber. Fiber 86 may be wrapped over aportion or all of bladder. Adhesive may be applied to bladder 72 beforeapplication of the fiber, during application of the fiber or afterapplication of the fiber or some combination thereof.

Successive layers of fiber may be used to build a completed balloon.Three pieces of fiber tape may be applied to bladder 72. This may befollowed by the application of fiber tape substantially over the maindiameter. This may be followed by application of fiber 86 on a portionor all of the proximal taper and stem of the bladder. This may befollowed by application of fiber 86 on a portion or all of the distaltip of the bladder. Lastly, a layer of PEN film may be applied. Layersof fiber tape or fiber may be omitted from this sequence. Layers offiber tape and fiber can be applied in any order. Polymer film may beapplied between layers, over the bladder or over the final layer offiber or fiber tape.

FIGS. 128A and 128B illustrate that the unconsolidated balloon may beplaced in a female mold 376. The unconsolidated balloon can include theshaft 2000, mandrel 230, bladder 72 and the various layers of fiber,fiber tape and film. The female mold 376 may contain a pocket for theunconsolidated balloon that is slightly larger than the unconsolidatedballoon.

FIG. 128C illustrates that the lower portion of FIG. 104 is a portion ofmandrel 230 and the upper portion of FIG. 104 is a portion of femalemold 376. The various layers of fiber, fiber tape and film can be spacedfrom the surface of the mold 376. This distance may be from about 0.005in. to about 0.050 in. When the bladder 72 is inflated, the layers 72can detach from the mandrel 230 and press firmly against the walls ofthe female mold 376.

FIG. 128C shows the layers after detaching from mandrel 230 but beforebeing pressed against female mold 376. This inflation and expansion mayserve to straighten and/or tension the fibers. Heat or light or anelectron beam or a combination thereof may be used with the inflation ofbladder 72 b and the passage of time to consolidate a fiber reinforcedballoon. Light or an electron beam may be applied, as part of aconsolidation, by inserting a source within a hollow lumen in a mandrel.The mandrel can then be removed as described infra.

A Method of Use

The device 2, for example including the balloon 20, can be used forKyphoplasty, angioplasty including CTO dilation, stent delivery,sinuplasty, valvuloplasty, drug or other fluid delivery through theballoon, radiopaque marking, incising the inside of a vessel (e.g., toopen or expand a vessel), brachytherapy, intentionally obstruct avessel, or combinations thereof. The device 2 can be used to deliver oneor more stents and/valves and/or emboli filters to the coronary bloodvessels (e.g., arteries or veins), carotid artery, peripheral bloodvessels, the GI tract, the biliary ducts, the urinary tract, thegynecologic tract, and combinations thereof. The device 2 can be used toprepare a cardiac annulus and/or the leaflets of a natural heart valvefor open or percutaneous (minimally invasive) valve replacement. Thedevice 2 can expand and deploy a percutaneously delivered heart valve

FIG. 129 illustrates a sagittal view of a patient and the spine 406. Thespine 406 can have vertebrae 408 and cervical, thoracic, lumbar andsacral regions 410, 412, 414, and 416. The device 2 can be used in orbetween vertebrae 408 in any region of the spine 406.

FIG. 130 illustrates a vertebrae 408 that can have cortical bone 418 andcancellous bone 420. The vertebrae 408 can have a vertebral body 422 avertebral process 424 and pedicles 426.

FIG. 131 illustrates a vertebra that a delivery tube 428, such as acannula, can be inserted against or into the pedicle. The delivery tube428 may have a inside diameter of less than about 6 mm, more narrowlyfrom about 2 mm to about 4.5 mm. A bone drill can be passed through thedelivery tube 428 to drill to create a drill void 430 in the cancellousbone. The bone drill can then be removed leaving the drill void 430 inthe cancellous bone.

FIG. 132 illustrates a cross section of a balloon 20. The balloon 20 canbe in a substantially inflated condition. The cross section area isshown. The balloon wall can have a balloon wall area 432.

FIG. 133 illustrates a cross section of balloon 20 in a substantiallydeflated and folded configuration. The balloon 20 is shown in a deliverytube or cannula with a delivery tube inside diameter 436 and a deliverytube area 434. The balloon 20 may be able to slide in the cannula.

The compression ratio of the balloon can be from about 3:1 to about 6:1,more narrowly from about 4:1 to about 5:1. The compression ratio can bethe ratio between the outside diameter of the substantially inflatedballoon (e.g., as shown in FIG. 132) and the inside diameter of thedelivery tube (e.g., the cannula as shown in FIG. 133).

The balloon can have a packing density equal to or greater than about40%, more narrowly greater than or equal to about 55%, yet more narrowlyequal to or greater than about 70%. The packing density can be thepercentage ratio between the cross sectional area of the walls of theballoon and the cross sectional area of the inside of the cannula.

The packing density and compression ratios for the balloon can remainsubstantially constant and the wall strength of the balloon can remainsubstantially constant with repeated packing and unpackings, and/orcompressings and uncompressings.

The balloon can be folded into the cannula and expanded about eighttimes while not significantly degrading the strength of the balloonwall.

FIG. 134 illustrates that the balloon can be inserted, as shown byarrow, through the delivery tube and into the drill void in thecancellous bone.

FIG. 135 illustrates that fluid pressure can be delivered, as shown byarrow 438, through the hollow shaft 2000 to the balloon 20. The balloon20 can inflate and expand, as shown by arrows 440. The expanding ballooncan compress the cancellous bone surrounding the drill void, creating alarger balloon void 442. The balloon 20 can be deflated and contracted.The balloon can be removed from the vertebral body and the deliverytube.

FIG. 136 illustrates that the diametric elasticity of existing medicalinflatable devices can be approximately 0.06 in./ATM and a typical burstpressure is about 3 ATM. The medical inflatable device 2 can have anexemplary diametric elasticity of 0.0004 in./ATM and a burst pressureabove 20 ATM (290 psi). For example, the burst pressure can be fromabout 290 psi to about 1500 psi. More narrowly, the burst pressure canbe from about 500 psi to about 1000 psi. For example, the burst pressurecan be about 500 psi, about 750 psi, about 1000 psi, about 1500 psi, orhigher than 1500 psi. For example, the burst pressure can be greaterthan 4 ATM with a diameter of greater than 20 mm, with a diametriccompliance of less than about 15%, or less than about 10% or less than5%.

FIG. 137 illustrates that a hollow balloon void 442 can be formed withinthe cancellous bone of the vertebral body. The balloon void 442 canremain in place when the balloon 20 is withdrawn from the vertebralbody.

FIG. 138 illustrates that a cement conduit 444 can be inserted, as shownby arrow 446, through the delivery tube and into the balloon void. Afiller, such as a bone cement 445, can be inserted, as shown by arrow448, into the balloon void 442.

FIG. 139 illustrates that additional bone cement 445 can be deliveredthrough the cement conduit 444 to the balloon void 442.

FIG. 140 illustrates that the balloon void can be substantially filledwith the bone cement. The bone cement can cure. The cement conduit canbe removed. The delivery tube can be removed.

FIGS. 141A through 141C illustrate a method of creating an initialballoon void with a first balloon similar to the methods shown herein.The first balloon 20 a can create an initial balloon void 442 a in thecancellous bone.

FIG. 141D illustrates that the pressure can be removed, as shown byarrow 450, and/or suction can be applied through the first hollow shaft.The first balloon 20 a can deflate and contract, as shown by arrows 452.The first balloon 20 a can be left in the initial balloon void. Thefirst hollow shaft can be pushed to the side of the delivery tube.

FIG. 141E illustrates that a second balloon attached to a second hollowtube can be inserted, as shown by arrow, through the delivery tube 428and into the initial balloon void 442 a. The second balloon can beplaced adjacent to the first balloon.

FIG. 141F illustrates that a first pressure can be delivered, as shownby arrow 438 a, through the first hollow shaft and into the firstballoon. The first balloon can undergo a first balloon final expansion,as shown by arrows 440 a. Before, concurrent with, or subsequent to thefirst balloon final expansion, a second pressure can be delivered, asshown by arrow 438 b, through the second hollow shaft and into thesecond balloon 20 b. The second balloon can undergo a second balloonexpansion, as shown by arrows 440 b. The first balloon final expansionand the second balloon expansion can create a final balloon void 442 bin the cancellous bone.

FIG. 141G illustrates that the first and second balloons can bedeflated, contracted and removed from the final balloon void 442 b. Thefinal balloon void can remain in place with the balloons removed. Thefinal balloon void can be larger than the initial balloon void.

FIG. 141H illustrates that a cement conduit can be inserted, as shown byarrow, through the delivery tube and into the balloon void. A filler,such as a bone cement, can be inserted into the final balloon void.

FIG. 141 i illustrates that the final balloon void can be substantiallyfilled with the bone cement. The bone cement can cure. The cementconduit can be removed. The delivery tube can be removed.

FIGS. 142A through 142C illustrate a method of created a balloon voidwith a balloon similar to the methods shown herein. The hollow shaft canbe attached to a cement conduit.

FIG. 142D illustrates that the bone cement can be delivered through thecement conduit and into the balloon void. The balloon can be deflatedand contracted, as shown by arrows, and/or the balloon can be pushed outof the way by pressurized bone cement delivered into the balloon void.The bone cement can contact the balloon with or without significantlydecaying, eroding or bonding to the balloon wall.

FIG. 142E illustrates that additional bone cement can be delivered tothe balloon void as the balloon contracts. The bone cement can partiallyor completely cure with our without being in contact with the balloon.The balloon wall can peel away or otherwise be separated from cured oruncured bone cement.

FIG. 142F illustrates that the final balloon void can be substantiallyfilled with the bone cement. The bone cement can cure. The hollow shaftand cement conduit can be removed. The delivery tube can be removed.

FIGS. 131 through 142F illustrate that the one or more balloons can beinserted into the vertebral body unilaterally, through a pedicle on onelateral side of the vertebra.

FIGS. 143A through 143 i illustrate a method for deploying the balloonsbilaterally, for example including one balloon inserted through each ofopposing pedicles 426 a and 426 b.

FIG. 143A illustrates that a first delivery guide 428 a can be throughthe left pedicle 426 a. A first drill void 430 a can be formed on theleft side of the vertebral body. A second delivery guide 428 b can bethrough the right pedicle 426 b. A second drill void 430 b can be formedon the left side of the vertebral body.

FIG. 143B illustrates that a first balloon 20 a can be inserted into theleft side of the vertebral body through the first delivery tube 428 a. Asecond balloon 20 b can be inserted into the right side of the vertebralbody through the second delivery tube 428 b.

FIG. 143C illustrates that the first balloon 20 a can be insertedthrough the first delivery tube 428 a. The second balloon 20 b can beinserted through the second delivery tube 428 b. The first and secondballoons can be inflated and expanded. The first and second balloons canform a first void segment 454 a and a second void segment 454 b,respectively, of the balloon void 442. The void segments 454 mayoverlap, as shown. The void segments 454 may be separate.

FIG. 143D illustrates that the second balloon can be deflated,contracted and removed from the balloon void.

FIG. 143E illustrates that a second cement conduit can be insertedthrough the second delivery tube and into the second void segment. Bonecement can be delivered through the second cement conduit and into thesecond void segment.

FIG. 143F illustrates that the bone cement can fill the second voidsegment and/or contact the first balloon. The second cement conduit canbe removed from the balloon void. The bone cement delivered to thesecond void segment can cure. The first balloon may not erode, decay orbond to the cement.

FIG. 143G illustrates that the first balloon can be deflated, contractedand withdrawn from the first void segment. The first void segment can beempty. The second void segment can be substantially filled with bonecement.

FIG. 143H illustrates that a first cement conduit can be insertedthrough the first delivery tube and into the first void segment. Bonecement can be delivered through the first cement conduit and into thefirst void segment.

FIG. 143 i illustrates that the first and second delivery tubes can beremoved from the patient. The balloon void can be substantially filledwith bone cement.

FIG. 144 illustrates that a guide block 456 may have a surface block topsurface 458 a and a block bottom surface 458 b. The block can havefinger depressions 460 where a user's fingers may grip the block. Theblock 456 can have a curved block channel 464 passing though the block456. The block channel 464 can terminate at a block top hole 462 a and ablock bottom hole 462 b. The block 456 can have one, two, or threeradiopaque markers 466 evenly or unevenly distributed about the block456. The radiopaque markers 466 can have a fixed dimensionalrelationship to block bottom hole 462 b.

The block can be partially or total radiolucent. The block top surfacecan be placed against a patient's back before a kyphoplasty procedure.The radiopaque markers can locate the block with respect to the patientanatomy. The block bottom hole can be located on the patient's backduring use.

FIG. 145 illustrates that an entry tool, such as a trocar 469 and adelivery tube, such as a cannula 468, may have curvatures thatsubstantially match the curvature of the block channel. The cannula 468can slide freely in the block channel. The cannula can be lubricated onthe outside diameter. The block top hole may be lubricated on the insidediameter. By holding block in place on the patient's anatomy, a medicalpractitioner may be able to advance the trocar and the cannula into avertebral body along a curved arc.

FIG. 146 illustrates that the cannula and trocar may advance furtherthough the block. The trocar can be a torsion shaft with a drill bit onthe distal end. Turning the torsion shaft can cause the drill to boreinto bone while being guided in a curved path by the cannula.

The cannula can be a flexible tube or series of links. The cannula, forexample as a tube, or series of links, may be steerable, for examplesimilar to a catheter or an endoscope.

FIG. 147 illustrates that the inflation system 470 can be attachable toa syringe 472 or other source of flow and pressure. The inflation system470 can include part or all of the hollow shaft 2000, an inner shaft 477a, a stiffening shaft 476, a hollow shaft lumen 154, a stiffening shaftlumen 478, an inflation port 482 and a stiffening rod control 480. Thedistal end of the stiffening shaft 476 can have a stiffening rod tip484.

The syringe 472 can be detachable or non-detachable from the remainderof the inflation system 470. The balloon 20 may be inflated by pushinginflation fluid, such as water or dye, from the syringe 472, into theinflation port 482, through the hollow shaft lumen 154 and into theballoon 20. The removable stiffening shaft 476 may be left in place tostiffen the inflation system 470 while positioning the balloon 20 in thebody. Once the balloon 20 is in place, the removable shaft stiffener 476can be removed to allow the hollow shaft 2000 additional freedom ofmotion outside the body.

The stiffening shaft 476 can be integral with or removably attached tothe stiffening rod 474. The stiffening rod tip 484 can have atraumaticgeometry, or a soft plastic or elastomeric tip that will minimizepuncture or damage the distal end of the balloon. The stiffener 476 canbe withdrawn manually automatically.

FIG. 148 illustrates that the inflation system 470 can have a balloon 20that can be inflated by pushing inflation fluid, such as water, saline,a gel or dye, from the syringe 472, into the inflation port 482, thoughthe hollow shaft lumen 154 and into the balloon 20.

The stiffening rod 474 can be removed from the inflation system or leftin place to stiffen the inflation system 470 while positioning theballoon 20 in the body. The inflation system can have a stiffening rodcontrol 480, for example a knob or handle on the proximal end of theinflation system to control the position of the stiffening rod. A sealadjacent to the stiffening rod control can prevent pressure fromescaping from the hollow shaft lumen. When the balloon 20 is at thetarget site, the stiffening rod 474 can be removed from the inflationsystem or left in place.

FIG. 149 illustrates that the stiffening rod control 480 can have innerthreads 486 b. A connector at the proximal end of the hollow shaft 2000can have outer threads 486 a. The stiffening rod control 480 canrotatably interface with the hollow shaft 2000 at the inner and outerthreads 486 b and 486 a.

The stiffening rod 474 can be attached to the inside of the distal endof the balloon 20. The stiffening rod can have a coupling (not shown)internal to the rod that can prevent the rod from applying torque to theballoon 20. The stiffening rod can be made from flexible high strengthfilaments (not shown). The balloon 20 may be inflated by pushinginflation fluid, such as water or dye, from the syringe 472, into aninflation port, though the hollow shaft lumen or inflation lumen andinto the balloon. Turning the stiffening rod control knob may cause theballoon to longitudinally expand or contract. The balloon can evert whenthe stiffening rod is withdrawn proximally. The balloon's distal end mayresemble the distal end 44 shown in FIG. 10 d.

FIG. 150A illustrates that the first balloon 20 a can be inserted intothe body through a working channel or delivery tube such as the cannula468. The first balloon 20 a in a deflated configuration can be smallerin diameter than the cannula inner diameter 488. The hollow shaft 2000can have a hollow shaft outer diameter 490. The hollow shaft outerdiameter 490 can be smaller than the cannula inner diameter 488. Forexample, the cannula inner diameter can be about 3.66 mm (0.144 in.).The hollow shaft outer diameter can be about 2 mm (0.09 in.), morenarrowly about 1.5 mm (0.060 in.), yet more narrowly about 0.8 mm (0.03in.). The stiffening rod can have a stiffener rod diameter. Thestiffener rod can have a stiffening rod diameter 492. The stiffener roddiameter can be about 1 mm (0.05 in.), or about 0.8 mm (0.03 in.), orabout 0.5 mm (0.02 in.).

The first balloon 20 a can be inflated in the body, for example creatinga first balloon void, lumen or pocket in the body. The first balloon 20a can be inflated in bone. The first balloon 20 a can be inflated in avertebra of the spine. The first balloon 20 a can then be deflated andpushed to the side of the cannula 468.

FIG. 150B illustrates that a second balloon 20 b can be inserted throughthe hollow shaft 2000 while the first balloon 20 a is positioned throughthe hollow shaft 2000. The first balloon 20 a and the second balloon 20b can be inserted concurrently through the hollow shaft 2000. The firstballoon 20 a can be deflated before the second balloon 20 b is inflated.

FIG. 150C illustrates that the first balloon 20 a and the second balloon20 b can be inserted into the initial void 442 a created by a drilland/or the first balloon 20 a. The first balloon 20 a and the secondballoon 20 b can be inflated in the initial void 42 a. The balloons 20can create a final balloon void 442 b, for example the final balloonvoid 442 b can be larger than the initial balloon void 442 a. Additionalballoons can be inserted into the void 442 and inflated to furtherenlarge the balloon void 442.

FIG. 151A illustrates that an inflation system 470 and the device 2 cancreate space in the body. The balloon 20 can be substantially compliantor substantially non-compliant. The hollow shaft 2000 can be attached toor integrated with the inflation system 470.

The inflation system 470 can be portable and can be held in and operatedby the user's hand. The inflation system 470 can provide a method forinflating the balloon 20. The inflation system 470 can advance andretract the stiffening rod to stiffen the balloon 20 during insertion ofthe balloon 20 into the body. The hollow shaft 2000 can have aninflation lumen between the inflation system and the balloon 20.

FIG. 151B illustrates that the inflation system 470 can have a pressuredelivery body 498, and a pressure control 494 (also element 590)attached to the pressure delivery body 498. The pressure control 494 canregulate the inflation of the balloon 20. The inflation system 470 canhave a stiffening rod control 480. The stiffening rod control 480 canmanipulate a stiffening rod 474 in the hollow shaft 2000. For example,the stiffening rod 474 can be advanced through or retracted from thehollow shaft 2000. The stiffening rod control 480 and/or the pressurecontrol 494 can have buttons, knobs, or combinations thereof. Thestiffening rod control 480 can be used to regulate the inflation of theballoon 20. A pressure gauge 496 attached to the lumen can show thepressure in balloon 20.

FIG. 151C illustrates that a pressure control interface 502 caninterface the pressure delivery body 498 with the pressure control 494.The pressure control interface 502 can be mating threads. The pressurecontrol interface 502 can have male threads on the pressure control 494that can mate to female threads on the pressure delivery body 498.Manipulating, such as turning, the pressure control interface 502, canincrease or decrease the pre-load volume. When the pressure control 494closes on the pre-load volume 504, the fluid in the pre-load volume 504can exit through the pressure delivery body port 506 (also element 592).The fluid in the pre-load volume 504 can have a water or a radiopaquedye.

The stiffening rod control 480 can have a stiffening rod controlinterface 500 can mate the stiffening rod control 480 with the pressuredelivery body 498. The stiffening rod control interface 500 can havemating threads. Turning the stiffening rod control 480 can extend andretract the stiffening rod 474.

The pressure control interface 502 can have male threads on the pressurecontrol 494 that can mate to female threads on the pressure deliverybody 498. The pressure control 494 and/or the stiffening rod control 480can have one or more pressure tight seals to prevent leakage through thecontrol.

FIG. 151C illustrates that the stiffening rod can block the pressuredelivery body port 506 when the stiffening rod is in a longitudinallyadvanced position.

The o-ring seats 226 can seat o-rings that can seal against the pressuredelivery body 498. The seals 286 in o-ring seats 226 can form apressurized volume between themselves that connects to the pressuredelivery body port 506 and the input of pressure gauge 496 (as shown inFIGS. 151C and 151D). The seals 286 in the o-ring seats 226 can form apressurized volume that does not always connect to the inflation lumen154. The inflation lumen 154 can connect to the internal volume ofballoon 20.

FIG. 151C illustrates that retracting the stiffening rod control 414(e.g., unscrewing the stiffening rod control 414) can cause thepressurized volume between seals 286 in o-ring seats 226 to no longer bein fluid communication with the inflation lumen, and/or the pressuredelivery body port and/or the input of the pressure gauge 496. Thestiffening rod control 480 (by, for example, rotating it) may cause thepressure delivery body port 506 and the input of pressure gauge 496 tobe connected to the inflation lumen 154 that leads to balloon 20.Manipulating the pressure control 494 can cause fluid to flow though thepressure delivery body port 506, through the inflation lumen 154 andinto the balloon 20, inflating the balloon 20.

The distal end of the device 2, for example the balloon 20, can beinserted into the body though a cannula. The stiffening rod control canbe manipulated to withdraw the stiffening member. The pressure controlcan be manipulated to move fluid from the pre-load volume 504 to theballoon volume.

Fluid entering the balloon 20 can cause the balloon 20 to inflate andcreate a balloon void in the body.

The pressure control 494 can be withdrawn from the pressure deliverybody 498. Fluid pressure can then move from the inside of balloon 20back into pre-load volume 504. The device 2 and inflation system 470 canthen be withdrawn from the body.

The fluid that is transferred from pre-load volume 504 to the balloonvolume can be sealed in the device before use, for example duringmanufacturing. The inflation system can have a fixed pre-load volume 504before use, such that a user does not need to add fluid to the pre-loadvolume 504 during use. The inflation system can be sealed or otherwisedesigned to prevent fluid, other than fluid added to the pre-load volume504 during manufacturing, from entering the pre-load volume 504. Thefluid in the pre-load volume 504 can be water, air, saline, radiopaquedye, a gel, or combinations thereof.

The volume of the pre-load volume 504 that can be delivered to theballoon volume can be set to inflate the balloon 20 to a pre-determinedinflation size. The pre-load volume can be sealed when the inflationgsystem is manufactured or fluid can be added or removed from thepre-load volume after manufacture of the inflation system and beforeuse.

For example, the pre-load volume 504 or maximum volume deliverable tothe balloon 20 (e.g., pre-load volume minus the volume of the pre-loadlumen 508 and the volume of the hollow shaft) can be inflate the balloon20 to a configuration where the one or more balloon walls 22 arestrained less than 5%, for example less than 3%, also for example lessthan 1%.

The stiffening rod 474 can obstruct fluid from entering the balloon 20from the pre-load volume 504 when the stiffening rod 474 is in a closedconfiguration. The stiffening rod 474 can not obstruct fluid fromentering the balloon 20 from the pre-load volume 504 when the stiffeningrod 474 is in an opened configuration. For example, the stiffening rodcan be withdrawn from the remainder of the inflation system in thesecond configuration. The stiffening rod can be configured not topuncture the balloon 20 in the closed or opened configuration.

FIG. 151D illustrates that the stiffening rod 474 can be in the openedconfiguration. The pre-load volume can be in fluid communication withthe balloon. The stiffening rod can not obstruct the pressure deliverybody port.

FIGS. 152A through 152C illustrate that the stiffening rod control 480can control fluid delivery to the balloon 20. The stiffening rod control480 can manipulate the stiffening rod. The stiffening rod control canretract proximally or extend distally the stiffening rod. The stiffeningrod can extend longitudinally along the hollow shaft 2000. The pressuregauge 496 can communicate the pressure in balloon 20 to the user. Theballoon 20 can be substantially compliant or substantiallynon-compliant. The hollow shaft 2000 can have an inflation lumenextending between the inflation system and the balloon 20.

FIG. 152C illustrates that the stiffening rod can have a stiffening rodinterface 499 that can mate to the inside of the pressure delivery body,for example at screw threads (not shown). The stiffening rod control canhave a pressure tight seal with the pre-load volume, such as at theo-ring seats. The stiffening rod control can be connected to or integralwith the stiffening rod. Turning the stiffening rod control can extendand retract the stiffening rod. A pressure disk 510 can have one or moreo-ring seats to form a pressure tight sliding seal with the pre-loadvolume and the stiffening rod. The pressure disk 510 can freely slideproximally and distally on the stiffening rod. A spring 514 can apply aforce on the pressure disk 510 to push the pressure disk 510 distally.O-ring seats (with o-rings, not shown) along a stiffening rod step 512can form a sealed and pressurized pre-load volume when the stiffeningrod control is retracted.

The pressure delivery body port 506 can be obstructed by the stiffeningrod step 512 when the stiffening rod is in a closed configuration, forexample, distally extended within the inflation system. The pre-loadvolume and the pressure gauge can be in fluid isolation, for example byone or more o-rings in o-ring seats, from the balloon volume. Thepre-load volume can be filled with air, water, saline, radiopaque dye, agel, or combinations thereof.

FIG. 152D illustrates that when the stiffening rod control 480 isretracted (for example, rotating the control 480), the stiffening rodcan retract proximally within the inflation system into an openedconfiguration. The stiffening rod step can move proximally. The pressuredelivery body port 506 can be in fluid communication with the balloon 20and the pressure gauge. Proximally moving the stiffening rod control 480can proximally move the pressure disk within the pre-load volume. Thepressure disk can force fluid out of the pre-load volume, through thepressure delivery body port and into the balloon 20. The pre-load volumecan decrease in volume. The balloon can inflate.

When the balloon 20 is positioned at a target site to be treated, thestiffening rod control 480 can be rotated and/or retracted to proximallymove the stiffening rod with respect to the pressure delivery body. Thestiffening rod control and/or the pressure control can regulate theinflation of the balloon 20, for example, by the fluid in the pre-loadvolume. The inflation and expansion of the balloon can create a voidvolume within in the body. The stiffening rod control and/or thepressure control can draw fluid from the balloon to the pre-load volume,deflating the balloon. The balloon can then be withdrawn from the targetsite.

The inflation system can be sealed to prevent fluid from the pre-loadvolume, or otherwise, from being delivered balloon volume until thestiffening rod has been proximally retracted (or distally extended,depending on the design).

FIG. 153 illustrates that the stiffening rod 474 can have an atraumaticor blunt stiffening rod tip 484 and be anchored at the proximal end orbase of the balloon 20. Inflation fluid can enter and exit the balloon20 through the lumen 154. The length of the stiffening rod 474 is chosensuch that when the balloon 20 is fully inflated, the blunt stiffeningtip 484 will extend into the balloon volume, but not touch the inside ofthe balloon wall.

FIGS. 154A and 154B illustrate that a deployment sheath 516 can beplaced . . . circumferentially around a pleated balloon 20 in acontracted configuration. The sheath 516 can contain the balloon andprevent radial expansion of the balloon. The sheath can be retractedwith respect to the balloon when the balloon is deployed through acannula or into a target site. The sheath can have an open distal end.The distal end can have leaflets 518. The balloon can be pushed throughthe leaflets 518 during deployment.

FIGS. 155A and 155B illustrates that the sheath can be placed aroundhalf of the balloon. The sheath can be placed around 180° of theballoon, as measured from the longitudinal axis. The balloon can exitfrom the distal end or lateral side of the sheath.

FIG. 156 illustrates that the inflation system 470 can connect to thehollow shaft or tube 2000. The hollow tube 2000 can be soft andflexible. The hollow tube 2000 can be permanently connected to theinflation system 470. The inflation system can have a delivery syringeand/or pump. The hollow tube 2000 may have a fitting (not shown) thatmay allow it be disconnected from the inflation system.

The hollow tube 2000 can connect to a fitting. The fitting can connectto the balloon 20. The balloon 20 is shown in a compacted condition suchthat it can moved though a tube and inserted in the body. The balloonvolume can be in fluid communication with the inflation system, forexample the pump.

The interior volumes of the tube the pump the balloon and the fittingmay be filled with saline solution, radiopaque dye, a gel, air,distilled water, or combinations thereof during manufacture. The volumeof fluid in the device 2 and the inflation system can be such that whenthe inflation system 470 has delivered a maximum output (i.e., all thefluid that can be delivered by the inflation system 470 has beendelivered) of fluid to the balloon, the balloon can be substantiallyinflated to a maximum rated inflation size for the balloon. Theinflation system can be sealed, for example to prevent addition orremoval of fluid from the system except when used with the balloon 20.

The inflation system can be configured to receive or evacuate excessfluid other than to the balloon. For example the inflation system canhave a connector or valve for receiving or evacuating fluid.

The inflation system 470 and/or device 2 can be sealed under vacuumduring manufacture. The balloon can be sealed under vacuum duringmanufacture. A membrane or soft plug can separate the inflation systemfrom the hollow shaft and/or balloon before use. Raising the pressure inthe inflation system can cause the membrane or plug to open and allowfluid into the balloon 20.

FIG. 157 illustrates that delivery rod or manipulation tool 520 can havea manipulation tool handle 528. The manipulation tool 520 can have amanipulation tool shaft 522. The manipulation tool 520 can have aninterface fitting or clasp 526. The manipulation tool shaft 522 can havea manipulation tool shaft diameter 524. The manipulation tool shaft 522can be solid or hollow. The manipulation tool shaft can be rigid orsemi-rigid.

FIG. 158 illustrates that the cannula 468 has been inserted to a targetsite within a body 530. The cannula 468 can have an inner lumen that canact as a delivery passage to the target site. The balloon 20 can beinserted into cannula 468 by hand. The balloon 20 can fit tightly orsnugly inside of the cannula 468. A force parallel to the longitudinalaxis of the cannula can be applied to advance the balloon 20 through thecannula. The hollow tube 2000 can be too flexible to reasonably deliverenough force to advance the balloon 2000 though the cannula.

FIG. 159 illustrates that the clasp 526 on the manipulation tool 520 caninterface with the fitting 594 so that the manipulation tool 520 canapply forces for maneuvering the balloon 20 outside and inside of thecannula 428. The manipulation tool 520 can translate the balloon 20longitudinally distal and/or proximal within the cannula. Themanipulation tool 522 can rotate the balloon within the cannula.

FIGS. 160 and 161 illustrate that the manipulation tool 520 can advancethe balloon 20 partially into the cannula.

FIG. 162 illustrates that the balloon 20 can be delivered to a targetsite in the body. The manipulation tool 520, for example at the clasp526, can be removed from the fitting 594. The hollow tube 2000 can behighly flexible. Wherein the hollow tube 2000 exits the cannula 468 thehollow tube can bend and lay substantially flat (as shown) on the topsurface of the cannula 468. The tube 2000 can not substantially obstructthe space directly above cannula 468. The hollow tube 2000 can be rigidor floppy and buckle easily. When cantilevered out 2 cm, the hollow tube2000 can deflect about 1 cm at less than about 0.015 N-m of torque, morenarrowly at less than about 0.005 N-m of torque.

FIG. 163A illustrates that the fitting 594 can have a distal shaftinterface. The distal shaft interface can have a hexagonal transversecross-section. FIG. 163B illustrates that the driving rod ormanipulation tool 520 can have a clasp 526 at the distal end of themanipulation tool shaft 522. The interface fitting 594 can be configuredto transmit force and torque through and removably attach to the clasp526. The clasp can have a hexagonal transverse cross-section or foursides of a hexagon. The clasp can have an open lateral side for thedistal shaft fitting 594 to be inserted and removed.

FIG. 164A illustrates that the fitting 594 can have a square orrectangular cross-section. FIG. 164B illustrates that the clasp 526 canhave a square or rectangular transverse cross-section or three sides ofa square.

FIG. 165A illustrates that the fitting 594 can have a one or more orpins or pegs extending laterally. The fitting 594 can have a circular oroval cross-section. FIG. 165B illustrates that the clasp 526 can haveone, two or more peg receivers. The distal shaft interface can have acircular, oval, partial circle, or partial oval transversecross-section.

FIGS. 166A and 166B illustrate that the fitting 594 can have a circularshape with a projecting rectangular feature. The clasp 526 can have afemale geometry that interfaces with rectangular feature of the fitting594. The clasp 526 can be semi-cylindrical.

FIG. 167 illustrates that fitting 594 can be a circular fitting with astop or longitudinal interference fitting element. The clasp 526 canhave a cylindrical or hemi-cylindrical shape, for example that canencompass more than angularly half of the fitting 594.

FIG. 168 illustrates that interface 594 can be a male shear geometry.The clasp 526 can be a scissor-type device having two pivoting graspingjaws.

FIG. 169 illustrates that interface 594 can have a male shear geometry.The clasp 526 can have a tweezer configuration having two resilientlybending jaws.

The clasp 526 may be able to pull, push or turn the fitting 594 throughthe cannula or at the target site.

FIG. 170 illustrates that the manipulation tool 520 can have jaw arms534 a and 534 b. The jaw arms can be parallel to each other and form acontinuous U-shaped distal configuration of the manipulation tool. Theinterface 594 can have a male shear geometry that can mate with thegeometry of the jaw arms 534 and/or the u-shaped configuration. Thefirst jaw arms 534 a can be rotationally attached to the second jaw arms534 b at a second pivot 532 b. The manipulation tool first and secondshafts 522 a and 522 b can be solid or hollow rigid rods or flexiblecables. The manipulation tool first shaft 522 a can be rotationallyattached to the first jaw arm 534 a at a first pivot 532 a. Pulling themanipulation tool first shaft 522 a with respect to the manipulationtool second shaft 522 b can cause the outward rotation, as shown byarrow, of the first jaw arm 534 a. This rotation can manipulate theposition and orientation of the balloon 20, and/or release the fitting594 from the manipulation tool 520.

FIG. 171A illustrates that the manipulation tool shaft 522 can have atapered profile. FIG. 171B illustrates that the manipulation tool shaft522 can have a circular profile. FIG. 171C illustrates that themanipulation tool shaft 522 can have an elliptical profile. FIG. 171Dillustrates that the manipulation tool shaft 522 can have a rectangularprofile. The corners of the rectangle may be rounded (not shown). FIG.171E illustrates that the manipulation tool shaft 522 can have ahemispherical profile. FIG. 171F illustrates that the manipulation toolshaft 522 can have a hemispherical profile wherein the normally flathalf of the surface can be convex. FIG. 171G illustrates that themanipulation tool shaft 522 can have a hemispherical profile wherein thenormally flat half of the surface can be concave. FIGS. 171H and 171 iillustrate that the manipulation tool shaft 522 can be a portion oftube, for example 120° or 240° of the tube. The manipulation tool shaft522 can be open on a lateral side. The manipulation tool shaft 522 canhave stops, notches or threads to keep the manipulation tool from beinginserted into the cannula past a certain length or allow the insertioninto the cannula to happen at a controlled rate.

FIGS. 172A and 172B illustrate that the manipulation tool 520 can have amanipulation tool first shaft 522 a radially inside a manipulation toolsecond shaft 522 b. The manipulation tool first shaft can have preformedtangs 534 a and 534 b at the distal end of the manipulation tool firstshaft. The distal end of the manipulation tool second shaft 522 b canhave a notch 538 that can radially constrain the tangs 534. The tangs534 a and 534 b can be formed to spring radially outward when notconstrained. When the manipulation tool second shaft is slid down towardthe fitting 594, the manipulation tool can press the tangs radiallyinward around the fitting, attaching the manipulation tool to thefitting. The fitting can be detached from the manipulation tool bysliding the manipulation tool second shaft away from the fitting. Themanipulation tool can have a lateral shaft port 536 through which thehollow tube 2000 (not shown) can extend through and exit themanipulation tool.

FIGS. 173A and 173B show that the manipulation tool 522 can straight orcurved. The curved manipulation tool shaft, shown in FIG. 173B, can bemade of a super elastic material, such as Nitinol. The manipulation toolshaft can be straightened for insertion through the cannula, and curveafter exiting the cannula 468.

FIGS. 174A and 174B illustrate that the inflation system 470 can have avalve system 542, a filled syringe 472, a t-connector 540, a cap 548 anda delivery pump or delivery syringe 588. The valve system 542 can beattached to a first port 560 a of the t-connector 540. The deliverysyringe 588 can be connected to a second port 560 b of the t-connector540. The cap 548 can be attached to the third port 550 c of thet-connector.

The check valve can have a check spring 550 and a valve ball 552. Theswabbable valve can be attached to the filled syringe at a syringeinterface 554. The swabbable valve can be attached to the check valve atan intervalve interface 556. The check valve can be attached to thet-connector at a first connector interface 558 a. The delivery syringecan be attached to the t-connector at a second connector interface 558b. The cap can be attached to the t-connector at a third connectorinterface 558 c. Any or all of the interfaces in the inflation systemcan be fixed or detachable connections, such as threaded connectors,luer connectors, glue, snap connectors, welds, or combinations thereof.

The valve system 542 can have a swabbable valve 544 connected to a checkvalve 546. The check valve 546 can be configured to allow flow into thet-connector 540 and prevent flow out of the t-connector 540 through thevalve system 542.

A pre-filled syringe 472 of fluid can be attached to the valve system.The fluid can be a saline solution, a radiopaque solution, water, a gel,an epoxy or curable polymer, or combinations thereof. The fluid can bepushed through the swabbable valve 544 and the check valve 546 and intothe delivery syringe 588. The delivery syringe plunger can be pulled asthe pre-filled syringe plunger is pushed.

After the fluid is delivered to the delivery syringe 588, the cap 548can be removed and a fluid conduit, such as the hollow shaft 2000, canbe attached to the t-connector third port 558 c in place of the cap 548.The fluid conduit 2000 can be positioned to have an output port at atarget site, such as into the balloon 20 in a vertebral body. Thedelivery syringe plunger can be deployed, forcing fluid through thefluid conduit and to the target site. The balloon 20 can inflate,creating a void within cancellous bone at the target site. The checkvalve and swabbable valve can minimize or prevent flow to the pre-filledsyringe during deployment of fluid from the delivery syringe to thefluid conduit. A manual valve does not need to be adjusted to direct thefluid to the fluid conduit.

FIG. 175 illustrates that a kit can be packaged to contain a balloon 20,driving rod or manipulation tool, fluid filled syringe 472, delivery orinflation syringe 588, or combinations thereof. The pre-filled syringecan be filled with the inflation fluid 586. The kit can be in a sterilepackage. The balloon can have a flexible conduit, such as the hollowtube 2000, attached to the first fluid port of the balloon 20.

FIG. 176 illustrates that the kit can have the balloon, driving rod, andthe inflation syringe. The inflation syringe can be filled with a fluidsuch as saline solution, a radiopaque solution, water or combinationsthereof. The kit can be in a sterile package.

FIG. 177 illustrates that the kit can have the balloon, driving rod, andthe inflation syringe. The balloon can be attached to and in fluidcommunication with a flexible tube. The flexible tube can be attached toand in fluid communication with the inflation syringe. The inflationsyringe can be pre-filled with the inflation fluid 586. The kit can bein a sterile package 584.

FIG. 178 shows a cross section of the heart 562. The heart 562 has anaorta 568, a left ventricle 570 and an aortic valve 564

FIGS. 179A and 179B and 179C illustrate that a guidewire 572 can beinserted through the aorta 568 and positioned in the left ventricle 570of the heart 562. The device 2 can be slidably inserted over theguidewire through the aorta 568. The device 2 may be in a deflated statewhen first placed in the aortic valve 564. The device 2 can bepositioned to align along the balloon longitudinal axis with the balloonwith the aortic valve leaflets 566. The device 2 can also be rotatedabout the balloon longitudinal axis to align with the aortic valve 564,for example when cutting apart attached leaflets 566 in a bicuspidaortic valve with a flange, vane, blade, other cutting element describedherein, or combinations thereof.

FIG. 179D shows the balloon 20 in an expanded configuration. The device20 can be non-compliant and open the aortic valve 564 to a precisedimension (for example, about 20 mm or about 24 mm). The balloon 20 canfixedly reconfigure and press the aortic valve leaflets 566 against theouter wall or annulus 582 of the aortic valve 564. The balloon 20 canradially expand the aortic valve annulus 582.

The balloon can have an annular lumen 160, as shown in FIGS. 36A through40. Natural blood flow through the aortic valve can flow through theannular lumen 160 when the balloon is in an inflated or expandedconfiguration in the aortic valve. The device can have a device valve.The device valve can open and close, for example depending on theventricular pressure against the device valve.

A radially expandable implant 156, such as a stent, anchoring annulus orother component of a replacement heart valve, including the replacementvalve, or combinations thereof, can be removably attached to the balloonbefore deployment. The balloon can deploy the radially expandableimplant 156 in the aortic valve, for example at the annulus of theaortic valve. The balloon can deliver and deploy a percutaneous aorticvalve at the aortic valve annulus.

FIG. 179E illustrates that the balloon can be deflated, contracted andwithdrawn from the aortic valve.

FIG. 179F shows the aortic valve in an opened configuration at a largerdimension than before the procedure.

The method described supra can be performed on an aortic, mitral,pulmonary, tricuspid or vascular valve.

FIG. 180A illustrates that the balloon can be positioned in a narrowed,atherosclerotic length of a blood vessel 574 having atheroscleroticplaque 576 on the interior of the vessel wall 578. The vessel 574 canhave a vessel lumen 580 through which blood can flow.

FIG. 180B illustrates that the balloon 20 can be inflated and expanded.The balloon 20 can remodel the vessel, pushing the sclerotic plaqueradially away from the balloon longitudinal axis. The balloon 20 candeploy a vascular stent to the sclerotic length of the vessel.

FIG. 180C illustrates that the balloon 20 can be deflated, contractedand removed from the narrowed length of the vessel 574. The vessel lumen574 can remain patent after the balloon is removed, for examplerestoring blood flow past the treated atherosclerotic length.

The balloon 20 can be implanted in the body semi-permanently orpermanently. The balloon 20 can have one, two or more openings for fluidentry and/or exit.

Any elements described herein as singular can be pluralized (i.e.,anything described as “one” can be more than one), and plural elementscan be used individually. Any species element of a genus element canhave the characteristics or elements of any other species element ofthat genus. The term “comprising” is not meant to be limiting. Theabove-described configurations, elements or complete assemblies andmethods and their elements for carrying out the invention, andvariations of aspects of the invention can be combined and modified witheach other in any combination.

We claim:
 1. A method for making an inflatable device for use in abiological body comprising: forming a leak-proof member from solid filmon a removable mandrel, said solid film comprising a film first pieceand a film second piece, wherein the forming comprises a first formingand a separate second forming, and wherein the first forming comprisesforming the film first piece over a first part of the mandrel, whereinthe film first piece is attached to the mandrel by an adhesive along aperimeter of said first panel, and wherein the second forming comprisesforming the film second piece over a second part of the mandrel; andremoving the mandrel from the leak-proof member, and wherein theinflatable device has no through lumen after the removing of themandrel.
 2. The method of claim 1, wherein the forming occurs at atemperature below 100° Celsius.
 3. The method of claim 1, wherein theforming occurs without solvation.
 4. The method of claim 1, furthercomprising dissolving the mandrel with a fluid comprising water.
 5. Themethod of claim 1, wherein the adhesive is a water-soluble tackingadhesive.
 6. The method of claim 1, further comprising trimming thefilm.
 7. The method of claim 1, wherein the solid film comprises athermoset film, and wherein the thermoset film comprises no fiber. 8.The method of claim 1, wherein the film comprises PEEK.
 9. The method ofclaim 1, wherein the first part of the mandrel is about half themandrel, and wherein the second part of the mandrel is about half themandrel not defined by the first part of the mandrel.
 10. The method ofclaim 1, further comprising bonding the film first piece to the filmsecond piece.
 11. The method of claim 1, wherein the inflatable deviceis leak-proof.
 12. The method of claim 1, wherein the inflatable devicehas a wall thickness, and wherein the wall thickness is less than about0.05 mm.
 13. The method of claim 1, wherein the mandrel comprises aeutectic or non-eutectic bismuth.
 14. The method of claim 1, wherein themandrel comprises polyvinylacetate.
 15. The method of claim 1, whereinthe first forming comprises applying a suction to the film first pieceand the second forming comprises separately applying a suction to thefilm second piece.
 16. A method for making an inflatable device for usein a biological body comprising: forming a leak-proof member with nothrough-lumen from at least two panels of a solid film on a removablemandrel, wherein forming comprises attaching a first of the at least twopanels to the mandrel by an adhesive along a perimeter of the firstpanel and further comprises separately pressure forming each of the twopanels of the film within a pressure chamber, and wherein the separatelypressure forming step comprises deforming each of the panels around atleast 90° of the mandrel, but less than 270° around the mandrel.
 17. Themethod of claim 16, wherein the forming further comprises applying asuction to at least one of the panels of the solid film.
 18. A methodfor making an inflatable device for use in a biological body comprising:forming a leak-proof member from first and second films positioned on aremovable mandrel, wherein the leak-proof member comprises a fiber, andwherein the first film comprises two panels, and wherein a first panelof the two panels of the first film is attached to the mandrel by anadhesive along a perimeter of said first panel, and wherein a secondpanel of the two panels of the first film is attached to the first panelby an adhesive along a perimeter of the second panel, each of said twopanels of the first film being separately and individually formed ontothe mandrel, and wherein the first film is on the radially inner side ofthe fiber with respect to the inflatable device, and wherein the secondfilm comprises a third panel and a fourth panel, and wherein the secondfilm is formed on the radially outer side of the fiber with respect tothe inflatable device, and wherein before being formed on the radiallyouter side of the fiber, the third panel comprises a sheet.
 19. Themethod of claim 18, wherein before being formed on the radially outerside of the fiber, the fourth panel is flat.
 20. The method of claim 18,wherein the sheet is flat.
 21. A method for making an inflatable devicefor use in a biological body comprising: forming a closed-ended,inflatable leak-proof member from first and second films positioned on aremovable mandrel, wherein the leak-proof member comprises a fiber, andwherein the first film comprises two panels, and wherein a first of thetwo panels of the first film is attached to the mandrel by an adhesivealong a perimeter of said first panel, and wherein the first film is onthe radially inner side of the fiber with respect to the inflatabledevice, and wherein the second film comprises a first panel and a secondpanel, and wherein the second film is formed on the radially outer sideof the fiber with respect to the inflatable device, and wherein thefirst panel of the second film covers at least 90° of the mandrel. 22.The method of claim 21, wherein the first panel of the second filmcovers about a first half of the mandrel.
 23. The method of claim 22,wherein the first half of the mandrel comprises a first lateral half.24. The method of claim 22, wherein the second panel of the second filmcovers about a second half of the mandrel.
 25. The method of claim 24,wherein the second half of the mandrel comprises a second lateral half.26. The method of claim 22, wherein at least one end of the mandrel hasa semi-spherical configuration, and wherein during the forming step, thesemi-spherical configuration is covered by at least a portion of both ofthe first and second panels of the first film.
 27. A method for makingan inflatable device for use in a biological body comprising: forming aninflatable leak-proof member with no through lumen from first and secondfilms positioned on a removable mandrel, wherein the leak-proof membercomprises a fiber, and wherein the first film comprises two panels, andwherein a first of the two panels of the first film is attached to themandrel by an adhesive along a perimeter of said first panel, andwherein the first film is on the radially inner side of the fiber withrespect to the inflatable device, and wherein the second film comprisestwo panels, at least one of the two panels of the second film comprisinga flat sheet, and wherein forming the leak-proof member comprisesforming the second film on the radially outer side of the fiber withrespect to the inflatable device, wherein the mandrel has a compoundcurved surface, and wherein forming the second film comprises applying apressure to deform the flat sheet over the compound curved surface. 28.A method for making an inflatable device for use in a biological bodycomprising: providing a removable mandrel with a compound curvedsurface; forming a leak-proof member with no through lumen from a firstfilm and a second film positioned on the removable mandrel, wherein theleak-proof member comprises a fiber; and wherein the first filmcomprises two panels, and wherein a first of the two panels covers abouthalf of the mandrel and is attached to the mandrel by an adhesive alonga perimeter of said first panel, and a second of the two panels coversabout an opposite half of the mandrel; and wherein the forming stepcomprises applying a pressure to separately deform the first of the twopanels and the second of the two panels over the compound curved surfaceof the mandrel.